Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-22 @ 11:51 AM
Study NCT ID:
NCT02623803
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bojaxhi.elrid@mayo.edu', 'phone': '904-956-3327', 'title': 'Dr. Elird Bojaxhi', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time patient initiated study drug infusion until hospital discharge (approximately 5-7 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Pain in Postoperative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1459', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline - arrival at the PACU', 'description': 'Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2050', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 4 hours post-operatively', 'description': 'Total opioid consumption in PACU converted to morphine equivalents in mg.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3989', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline - arrival at the PACU', 'description': 'Pain will be measured at rest upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain With Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5285', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline - arrival at the PACU', 'description': 'Pain with coughing will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0697', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'Overall pain will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1029', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'Pain at rest will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain With Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3136', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'Pain with coughing will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2196', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 12 hours post-operatively', 'description': 'Overall pain will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3057', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 12 hours post-operatively', 'description': 'Pain at rest will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain With Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0404', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 12 hours post-operatively', 'description': 'Pain with coughing will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5314', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day 1 at 1am', 'description': 'Overall pain will be measured on post-operative day 1 at 1am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3166', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day 1 at 1 am', 'description': 'Pain at rest will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain With Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2363', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day 1 at 1 am', 'description': 'Pain with coughing will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9171', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day 1 at 1 pm', 'description': 'Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4194', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day 1 at 1 pm', 'description': 'Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain With Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7073', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day 1 at 1 pm', 'description': 'Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Time to First Flatus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5107', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 weeks postoperatively', 'description': 'Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Time to First Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8339', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 weeks postoperatively', 'description': 'Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8927', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours post-operatively', 'description': 'Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'classes': [{'title': 'Able to breathe easily', 'categories': [{'measurements': [{'value': '9.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Been able to enjoy food', 'categories': [{'measurements': [{'value': '6.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Feeling rested', 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Have had a good sleep', 'categories': [{'measurements': [{'value': '7.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Able to look after personal toliet and hygiene', 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Able to communicate with family or friends', 'categories': [{'measurements': [{'value': '9.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Getting support from hospital doctors and nurse', 'categories': [{'measurements': [{'value': '8.8', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Able to return to work or usual home activities', 'categories': [{'measurements': [{'value': '5.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Feeling comfortable and in control', 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Having a feeling of general well-being', 'categories': [{'measurements': [{'value': '7.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate pain', 'categories': [{'measurements': [{'value': '7.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Severe pain', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Nausea or vomiting', 'categories': [{'measurements': [{'value': '8.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Feeling worried or anxious', 'categories': [{'measurements': [{'value': '7.7', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Feeling sad or depressed', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 post-operatively', 'description': "This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.\n\nLidocaine'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.\n\nPlacebo D5W'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.3', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '65.1', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '65.7', 'spread': '67.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'American Society of Anesthesiologists (ASA) Physical Status Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'ASA II', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'ASA III', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: ASA classification defines ASA I as a normal healthy patient, ASA II as a patient with a mild systemic disease without substantive functional limitations and an ASA III as a patient with a severe systemic disease with substantive functional limitations. A lower classification (I/II) is a more positive reflection of overall health compared to a higher classification (III).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-30', 'size': 337447, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-19T12:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2015-11-16', 'resultsFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-12', 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Pain in Postoperative Period', 'timeFrame': 'baseline - arrival at the PACU', 'description': 'Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Opioid Consumption', 'timeFrame': 'up to 4 hours post-operatively', 'description': 'Total opioid consumption in PACU converted to morphine equivalents in mg.'}], 'secondaryOutcomes': [{'measure': 'Pain at Rest', 'timeFrame': 'baseline - arrival at the PACU', 'description': 'Pain will be measured at rest upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain With Coughing', 'timeFrame': 'baseline - arrival at the PACU', 'description': 'Pain with coughing will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Overall Pain', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'Overall pain will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain at Rest', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'Pain at rest will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain With Coughing', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'Pain with coughing will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Overall Pain', 'timeFrame': 'approximately 12 hours post-operatively', 'description': 'Overall pain will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain at Rest', 'timeFrame': 'approximately 12 hours post-operatively', 'description': 'Pain at rest will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain With Coughing', 'timeFrame': 'approximately 12 hours post-operatively', 'description': 'Pain with coughing will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Overall Pain', 'timeFrame': 'post-operative day 1 at 1am', 'description': 'Overall pain will be measured on post-operative day 1 at 1am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain at Rest', 'timeFrame': 'post-operative day 1 at 1 am', 'description': 'Pain at rest will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain With Coughing', 'timeFrame': 'post-operative day 1 at 1 am', 'description': 'Pain with coughing will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Overall Pain', 'timeFrame': 'post-operative day 1 at 1 pm', 'description': 'Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain at Rest', 'timeFrame': 'post-operative day 1 at 1 pm', 'description': 'Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain With Coughing', 'timeFrame': 'post-operative day 1 at 1 pm', 'description': 'Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Length of Time to First Flatus', 'timeFrame': 'up to 3 weeks postoperatively', 'description': 'Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return.'}, {'measure': 'Length of Time to First Bowel Movement', 'timeFrame': 'up to 3 weeks postoperatively', 'description': 'Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return.'}, {'measure': 'Total Opioid Consumption', 'timeFrame': 'up to 24 hours post-operatively', 'description': 'Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.'}, {'measure': 'Quality of Recovery', 'timeFrame': 'Day 15 post-operatively', 'description': "This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatectomy']}, 'referencesModule': {'references': [{'pmid': '13521304', 'type': 'BACKGROUND', 'citation': 'DE CLIVE-LOWE SG, DESMOND J, NORTH J. Intravenous lignocaine anaesthesia. Anaesthesia. 1958 Apr;13(2):138-46. doi: 10.1111/j.1365-2044.1958.tb08045.x. No abstract available.'}, {'pmid': '14448503', 'type': 'BACKGROUND', 'citation': 'BARTLETT EE, HUTSERANI O. Xylocaine for the relief of postoperative pain. Anesth Analg. 1961 May-Jun;40:296-304. No abstract available.'}, {'pmid': '11091234', 'type': 'BACKGROUND', 'citation': 'Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.'}, {'pmid': '17197840', 'type': 'BACKGROUND', 'citation': 'Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.'}, {'pmid': '3631561', 'type': 'BACKGROUND', 'citation': 'Wallin G, Cassuto J, Hogstrom S, Linden I, Faxen A, Rimback G, Hedner T. Effects of lidocaine infusion on the sympathetic response to abdominal surgery. Anesth Analg. 1987 Oct;66(10):1008-13.'}, {'pmid': '11460813', 'type': 'BACKGROUND', 'citation': 'Wheatley RG, Schug SA, Watson D. Safety and efficacy of postoperative epidural analgesia. Br J Anaesth. 2001 Jul;87(1):47-61. doi: 10.1093/bja/87.1.47. No abstract available.'}, {'pmid': '14515286', 'type': 'BACKGROUND', 'citation': 'Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. Br J Surg. 2003 Oct;90(10):1195-9. doi: 10.1002/bjs.4223.'}, {'pmid': '18844267', 'type': 'BACKGROUND', 'citation': 'Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.'}, {'pmid': '17667496', 'type': 'BACKGROUND', 'citation': 'Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11.'}, {'pmid': '2316883', 'type': 'BACKGROUND', 'citation': 'Rimback G, Cassuto J, Tollesson PO. Treatment of postoperative paralytic ileus by intravenous lidocaine infusion. Anesth Analg. 1990 Apr;70(4):414-9.'}, {'pmid': '12799407', 'type': 'BACKGROUND', 'citation': 'Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.'}, {'pmid': '22290456', 'type': 'BACKGROUND', 'citation': 'Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.'}, {'pmid': '10740540', 'type': 'BACKGROUND', 'citation': 'Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.'}, {'pmid': '21621130', 'type': 'BACKGROUND', 'citation': 'Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.'}, {'pmid': '17061640', 'type': 'BACKGROUND', 'citation': 'Gower ST, Quigg CA, Hunt JO, Wallace SK, Myles PS. A comparison of patient self-administered and investigator-administered measurement of quality of recovery using the QoR-40. Anaesth Intensive Care. 2006 Oct;34(5):634-8. doi: 10.1177/0310057X0603400514.'}, {'pmid': '10969322', 'type': 'BACKGROUND', 'citation': 'Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida.\n* Age 18 - 80 years old\n* American Society of Anesthesiologist (ASA) class I - III\n* BMI \\< 40\n* Ability to understand and read English\n\nExclusion Criteria:\n\n* Not able or willing to sign consent\n* Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine).\n* History of epilepsy or currently receiving treatment for seizures\n* Severe hepatic insufficiency (Child-Pugh Score C)\n* Renal insufficiency (creatinine clearance less than 30 mL/minute)\n* Advance heart failure (NY Heart failure stage 3 or greater; Ejection function \\<30%)\n* Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers\n* Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate\n* Patients with active psychiatric disorders or cognitive dysfunction\n* Pregnancy or lactating\n* Enucleation, central, and distal pancreatectomy\n* Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)'}, 'identificationModule': {'nctId': 'NCT02623803', 'briefTitle': 'Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies', 'orgStudyIdInfo': {'id': '15-003955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.', 'interventionNames': ['Drug: Placebo D5W']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo D5W', 'type': 'DRUG', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Elird Bojaxhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elird Bojaxhi, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}