Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-27 @ 5:13 PM
Study NCT ID:
NCT00913068
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2009-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postoperative Pain Control for Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D004304', 'term': 'Dosage Forms'}], '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'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rrendon@dal.ca', 'phone': '9024736604', 'title': 'Dr. Ricardo A. Rendon', 'organization': 'Capital District Health Authority'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TAP Arm', 'description': 'in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Post Operative Pain Control', 'description': "Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.", 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Milligrams of Opiates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAP Arm', 'description': 'in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm'}, {'id': 'OG001', 'title': 'Standard Post Operative Pain Control', 'description': "Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction."}], 'classes': [{'categories': [{'measurements': [{'value': '5.15', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '2.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '2, 6,12, 24, 48 and 72 hours', 'description': 'mean number of milligrams used postoperatively', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In order to achieve a power of 0.9 with a 20% change in pain scores, 40 patients were needed per arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAP Arm', 'description': 'in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm'}, {'id': 'FG001', 'title': 'Standard Post Operative Pain Control', 'description': "Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': '\\<75, open radical prostatectomy, December 2010 - September 2011. Ketorolac, paralytics, fentanyl, propofol, sevoflurane or isofluroane use was at discretion of anesthetist. Patients requiring spinal or epidural anesthetics, history of chronic pain, chronic opiate use and and need for second general anesthetic within the first 24 h were excluded.', 'preAssignmentDetails': '16 were excluded before starting the study due to chronic opiate use, or for requiring a secondary general anesthetic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAP Arm', 'description': 'in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm'}, {'id': 'BG001', 'title': 'Standard Post Operative Pain Control', 'description': "Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2009-06-01', 'resultsFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-03', 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Milligrams of Opiates', 'timeFrame': '2, 6,12, 24, 48 and 72 hours', 'description': 'mean number of milligrams used postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radical prostatectomy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The researchers propose to investigate a relatively new anesthetic procedure, in order to maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.', 'detailedDescription': "Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). As the amount of opiates used can be significant, we have to be aware of their inherent risks. Opiates have an excellent pain control profile, working peripherally by decreasing the amount of neurotransmitters released from neurons involving noxious stimuli, and also in their central processing. Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.\n\nThus we propose the use of a relatively new regional anesthetic technique be employed to further decrease the need for opiates in our prostatectomy patients' post-op course, while adequately controlling their pain."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prostate cancer for radical prostatectomy\n\nExclusion Criteria:\n\n* chronic pain or opiate use'}, 'identificationModule': {'nctId': 'NCT00913068', 'acronym': 'TAP', 'briefTitle': 'Postoperative Pain Control for Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Post Operative Analgesia Using the Transverse Abdominal Plan (TAP) Block in Patients Undergoing a Radical Retropubic Prostatectomy (RRP)', 'orgStudyIdInfo': {'id': 'version 2 July 13, 2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP arm', 'description': 'in the experimental arm, the procedure will consist of the staff urologist injecting local anesthetic into the anterior abdominal wall bilaterally from the inside of the abdomen at the end of their surgery', 'interventionNames': ['Procedure: Transverse Abdominal Plan (TAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard post operative pain control', 'description': "Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.", 'interventionNames': ['Procedure: standard post op pain control']}], 'interventions': [{'name': 'Transverse Abdominal Plan (TAP)', 'type': 'PROCEDURE', 'otherNames': ['lidocaine', 'ropivacaine'], 'description': 'An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.', 'armGroupLabels': ['TAP arm']}, {'name': 'standard post op pain control', 'type': 'PROCEDURE', 'otherNames': ['timed assessments for pain and medications'], 'description': 'opiates', 'armGroupLabels': ['standard post operative pain control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Ricardo A Rendon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Elizabeth Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ricardo Rendon', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}