Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 12:02 PM
Study NCT ID:
NCT04171050
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)
Sponsor:
Organization:
Raw JSON
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'310-983-1023', 'title': 'Tamara Grisales, MD', 'organization': 'University of California, Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks postoperatively', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 7, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pudendal nerve entrapment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anesthetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention at 48hr', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hospital readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Narcotic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections'}, {'id': 'OG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '6.75', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after surgery', 'description': 'Measured in morphine milligram equivalents (MME) at 24 hours', 'unitOfMeasure': 'MME', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Narcotic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections'}, {'id': 'OG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours after surgery', 'description': 'Measured in MME at 48 hours', 'unitOfMeasure': 'MME', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections'}, {'id': 'OG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'classes': [{'title': '0-2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '4-8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '8-12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '2', 'groupId': 'OG000'}, {'value': '3', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}, {'value': '4', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 24 hours, and 48 hours after surgery', 'description': 'Average pain score by Numerical Rating Scale (NRS). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were not present for 8-12 hour assessment (outpatient surgery so they were sent home)'}, {'type': 'SECONDARY', 'title': 'Return to Normal Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections'}, {'id': 'OG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '18'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks after surgery', 'description': 'Days to return to normal activity, defined as walking, sitting, and performing daily household tasks comfortably. Upon discharge, all participants received a diary to record the date they returned to normal daily activities. Participants were contacted at 2 and 6 weeks postoperatively either by telephone or during their scheduled office visit and were asked about their time to return to normal activity.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Postoperative Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Local Anesthesia', 'description': 'This group was assigned usual care, which involved local anesthesia administered per surgeon preference'}, {'id': 'OG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'classes': [{'title': '1 - at 48 hours', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '2 - at 48 hours', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3 - at 48 hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '4 - at 48 hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 - at 48 hours', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not obtained at 48 hours', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 - at 2 weeks', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': '2 - at 2 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '3 - at 2 weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4 - at 2 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '5 - at 2 weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not obtained at 2 weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after surgery, 2 weeks after surgery', 'description': 'Satisfaction with postoperative pain control was assessed using a verbal scale of 1=very satisfied, 2=Somewhat satisfied, 3=Neither satisfied nor dissatisfied, 4=Somewhat dissatisfied, 5=very dissatisfied', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study, per Participant Flow.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections'}, {'id': 'OG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '24'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tracked by hour through time of patient discharge (up to 72 hours)', 'description': 'Tracked in hours', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery\n\nLocal anaesthetic: Local anesthesia injections'}, {'id': 'FG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Local Anesthesia', 'description': 'This group was assigned usual care, which involved local anesthesia administered per surgeon preference'}, {'id': 'BG001', 'title': 'Group 2: Local Anesthesia Plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery\n\nPudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '69'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '70'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Refused to answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-30', 'size': 2766961, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-12T13:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The providers will know what intervention the patients underwent, but the patients and the care team obtaining pain scores in the hospital will be blinded to the intervention'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a prospective blinded randomized controlled trial. We will recruit women who are undergoing vaginal prolapse repair surgery with a Female Pelvic Medicine and Reconstructive Surgery fellowship-trained provider within the University of California, Los Angeles (UCLA) Health System.\n\nWomen will be recruited prior to undergoing vaginal reconstructive surgery. They will then be randomized to control group with standard of care with local anesthesia used during surgery (Group 1) or PNB in addition to use of local anesthesia typically used during surgery (Group 2).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2019-11-15', 'resultsFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-30', 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Narcotic Use', 'timeFrame': '24 hours after surgery', 'description': 'Measured in morphine milligram equivalents (MME) at 24 hours'}, {'measure': 'Narcotic Use', 'timeFrame': '48 hours after surgery', 'description': 'Measured in MME at 48 hours'}], 'secondaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 24 hours, and 48 hours after surgery', 'description': 'Average pain score by Numerical Rating Scale (NRS). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).'}, {'measure': 'Return to Normal Daily Activities', 'timeFrame': '6 weeks after surgery', 'description': 'Days to return to normal activity, defined as walking, sitting, and performing daily household tasks comfortably. Upon discharge, all participants received a diary to record the date they returned to normal daily activities. Participants were contacted at 2 and 6 weeks postoperatively either by telephone or during their scheduled office visit and were asked about their time to return to normal activity.'}, {'measure': 'Patient Satisfaction With Postoperative Recovery', 'timeFrame': '48 hours after surgery, 2 weeks after surgery', 'description': 'Satisfaction with postoperative pain control was assessed using a verbal scale of 1=very satisfied, 2=Somewhat satisfied, 3=Neither satisfied nor dissatisfied, 4=Somewhat dissatisfied, 5=very dissatisfied'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Tracked by hour through time of patient discharge (up to 72 hours)', 'description': 'Tracked in hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain Management', 'Pudendal Nerve Block (PNB)', 'Vaginal Reconstruction'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '38640500', 'type': 'DERIVED', 'citation': 'Torosis M, Fullerton M, Kaefer D, Nitti V, Ackerman AL, Grisales T. Pudendal Block at the Time of Transvaginal Prolapse Repair: A Randomized Controlled Trial. Urogynecology (Phila). 2024 Aug 1;30(8):706-713. doi: 10.1097/SPV.0000000000001448. Epub 2024 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'Patients will undergo their vaginal reconstructive surgery in the usual manner, but will also be randomly assigned on the day of surgery to either receive the extra injection of numbing medication at the onset of surgery or not. The chances they will be assigned to the additional injection is 50%. Their care in the hospital and after surgery will be the same. They will participate in the study for a total of 6 weeks during which time they will be asked to complete two phone surveys, during which a provider will check in on pain level and pain medication use, and one office visit at 6 weeks. The office visit is part of their routine care and would be a scheduled visit regardless if they participated in the study or not. If they are unable to return to the office for a postoperative visit at 6 weeks, they will be contact by phone instead to obtain information on satisfaction with postoperative care, any complications after surgery, and overall how they are doing after surgery.', 'detailedDescription': "PROTOCOL SUMMARY AND/OR SCHEMA\n\nTo determine whether administration of a PNB at time of vaginal reconstructive surgery can reduce use of narcotics and reported pain scores in the immediate postoperative period within the setting of multimodal postoperative pain control of ERAS. Women \\>18yo undergoing vaginal reconstructive surgery without a hysterectomy will be randomized to either standard of care with typical use of local anesthetic during their surgery versus perioperative PNB in addition to typical use of local anesthetic during their surgery. PNB will be performed with 0.5% bupivacaine and 10cc will be injected bilaterally. All patients will be on a standard preoperative and postoperative multimodal pain regimen. Patients will be followed until 6 weeks after surgery.\n\nOVERVIEW OF STUDY DESIGN/INTERVENTION\n\nThis will be a prospective blinded randomized controlled trial. We will recruit women who are undergoing vaginal prolapse repair surgery with a Female Pelvic Medicine and Reconstructive Surgery fellowship-trained provider within the UCLA Health System. Women will be recruited prior to undergoing vaginal reconstructive surgery. They will then be randomized to control group with standard of care with local anesthesia used during surgery (Group 1) or PNB in addition to use of local anesthesia typically used during surgery (Group 2).\n\nAll pain medication will be standardized. Preoperative medications per our ERAS protocol will include oral acetaminophen 1000mg, gabapentin 600mg, and celecoxib 400mg. During surgery the patient will undergo their randomized intervention as either Group 1 or Group 2. Postoperative medications per our ERAS protocol including scheduled acetaminophen 1,000mg PO every 6 hours and ketorolac 30mg IV every 6 hours. For supplemental pain medication patients will have the following available: tramadol 50mg PO every 6 hours as needed for moderate pain (pain 4-6/10 on NRS scale), tramadol 100mg PO every 6 hours as needed for severe pain (pain 7-10/10 on NRS scale), and oxycodone 5mg PO every 4 hours as needed for breakthrough pain as supplemental pain medication. If the above regimen does not allow for sufficient pain control then additional hydromorphone IV 0.2mg or morphine IV 2mg can be ordered by the provider as needed, but will not be standard in the postoperative order set. The providers will know what intervention the patients underwent, but the patients and the care team obtaining pain scores in the hospital will be blinded to the intervention.\n\nThe patients' pain scores on the numeric rating scale (NRS) and supplemental opioid use measured in morphine milligram equivalent (MME) will be tracked during their hospitalization, which is typically a 23-hour observation. They will then be called at 48 hours for further follow-up on pain score by NRS and asked how much opioid medication they have taken since leaving the hospital and their overall satisfaction with their pain control. To help with the determination of supplemental pain medication used and pain scores, the patients will be provided a worksheet upon discharge that outlines their recommended medication routine, allows them to record their supplemental opioid medication use with dose and time, and also provides space for them to record their pain score at 48 hours post operatively. The patient will then be contacted at 2 weeks after surgery to determine if they have returned to normal activities (walking, sitting, and performing daily household tasks comfortably) and if so at what point this occurred, as well as their overall satisfaction with their postoperative pain control again. The two week contact will be either a phone call or clinic visit depending on the provider's preference for patient follow-up. The last point of contact will be at 6 weeks to determine time to return to normal activities, if they had not met this milestone at the 2-week contact, and again assess their overall satisfaction with their postoperative pain control. If a patient is discharge same day instead of admitted for 23-hour observation they will also receive a call at 24 hours postoperative to check on pain score and supplemental pain medication used."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women over the age of 18 undergoing vaginal reconstructive surgery without a hysterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age \\> 18 years old\n* English speaking\n* Undergoing vaginal reconstructive surgery of at least 2 compartments (anterior vaginal wall, posterior vaginal wall, and/or apical suspension including hysteropexy, uterosacral ligament suspension, or sacrospinous ligament fixation)\n\nExclusion Criteria:\n\n* Hysterectomy at time of surgery-is variable in duration which may affect response to PNB\n* Inability to tolerate opioids-allergy or medical contraindication\n* Inability to tolerate local anesthetic agents-allergy or medical contraindication\n* Inability to tolerate NSAIDS-allergy or medical contraindication\n* Inability to tolerate acetaminophen-allergy or medical contraindication\n* Coagulation disorder\n* Chronic pain syndrome using opioid medication on a regular basis prior to surgery'}, 'identificationModule': {'nctId': 'NCT04171050', 'briefTitle': 'Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)', 'orgStudyIdInfo': {'id': 'Pudendal Enhancement of ERAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Local Anesthesia', 'description': 'Standard of care with local anesthesia used during surgery', 'interventionNames': ['Drug: Local anaesthetic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Local Anesthesia plus Pudendal Nerve Block', 'description': 'Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery', 'interventionNames': ['Drug: Pudendal Nerve Block plus anesthesia']}], 'interventions': [{'name': 'Local anaesthetic', 'type': 'DRUG', 'description': 'Local anesthesia injections', 'armGroupLabels': ['Group 1: Local Anesthesia']}, {'name': 'Pudendal Nerve Block plus anesthesia', 'type': 'DRUG', 'description': 'Local anesthesia injections plus a pudendal nerve block', 'armGroupLabels': ['Group 2: Local Anesthesia plus Pudendal Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tamara Grisales', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}