Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-03-17 @ 3:21 AM
Study NCT ID:
NCT01679106
Status:
TERMINATED
Last Update Posted:
2016-05-23
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study closed because of low enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-20', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of continuous TAP analgesia and pain scores', 'timeFrame': 'day 1', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'Effect of TAP analgesia and opioid requirements', 'timeFrame': 'Day 1', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'Effect of continuous TAP analgesia on pain scores', 'timeFrame': 'Day 2', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'effect of continuous TAP analgesia on pain scores', 'timeFrame': 'Day 3', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'Effect of continuous TAP analgesia on pain scores', 'timeFrame': '30 days', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'Effect of TAP analgesia on opioid requirements', 'timeFrame': 'Day 2', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'Effect of TAP analgesia on opioid requirements', 'timeFrame': 'Day 3', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}, {'measure': 'Effect of TAP analgesia on opioid requirements', 'timeFrame': 'Day 30', 'description': 'The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal transplant', 'flank incision'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8.\n\nGroup 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA\n\nThe TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic benefit. In addition, the presence of any pain at the incision site will be noted at the 1 month surgical follow-up to determine any evidence of chronic pain.\n\nThe investigators hypothesis is that unilateral kidney transplant patients with a continuous TAP catheter will have decreased pain scores and opioid usage compared to those receiving standard analgesic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is \\>18 years of age\n* The patient has provided written informed consent and understands the explanation of the protocol.\n* The patient is scheduled to have a unilateral renal transplant with a flank incision\n\nExclusion Criteria:\n\n* Patients aged \\<18.\n* Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.\n* Patients who are unable to understand the verbal analog pain scale.\n* Patients who decline participation.\n* Patients with a midline abdominal incision.\n* Combined transplants, ie. Kidney-pancreas'}, 'identificationModule': {'nctId': 'NCT01679106', 'briefTitle': 'The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'orgStudyIdInfo': {'id': '12-559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Fentanyl IV PCA and placebo TAP catheter', 'description': 'Patients will receive Fentanyl IV PCA and placebo TAP catheter.', 'interventionNames': ['Other: Fentanyl IV PCA and placebo TAP catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAP catheter with continuous infusion of Ropivicaine', 'description': 'Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.', 'interventionNames': ['Other: TAP catheter with Ropivicaine']}], 'interventions': [{'name': 'TAP catheter with Ropivicaine', 'type': 'OTHER', 'description': 'Patients will receive TAP catheter with continuous infusion of Ropivicaine.', 'armGroupLabels': ['TAP catheter with continuous infusion of Ropivicaine']}, {'name': 'Fentanyl IV PCA and placebo TAP catheter', 'type': 'OTHER', 'description': 'Patients will receive placebo TAP catheter with Fentanyl IV PCA.', 'armGroupLabels': ['Fentanyl IV PCA and placebo TAP catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ehab Farag, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}