Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 4:30 PM
Study NCT ID:
NCT01608035
Status:
COMPLETED
Last Update Posted:
2016-05-20
First Post:
2012-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010591', 'term': 'Phantom Limb'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2012-05-11', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'Post-op day 0-7', 'description': 'MAR records will be used to calculate opioid consumption'}], 'secondaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'Post-op day 0-7 and at 3months', 'description': 'VAS will be used (0-10)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sciatic catheter', 'stump catheter', 'below knee amputation'], 'conditions': ['Ischemia', 'Phantom Limb Pain', 'Vascular Disease', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation', 'detailedDescription': 'We wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. The information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. The primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. The secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing a below knee amputation\n* 16 years of age or older\n* regional anesthetic will be used as part of the surgery\n\nExclusion Criteria:\n\n* pregnant\n* allergic to local anesthetic or ultrasound jelly\n* a contraindication to having a peripheral nerve block catheter'}, 'identificationModule': {'nctId': 'NCT01608035', 'briefTitle': 'Sciatic Perineural Versus Stump Catheter for Below Knee Amputation', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes', 'orgStudyIdInfo': {'id': 'H12-00693'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sciatic catheter', 'interventionNames': ['Procedure: Sciatic catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stump catheter', 'interventionNames': ['Procedure: Stump catheter']}], 'interventions': [{'name': 'Sciatic catheter', 'type': 'PROCEDURE', 'otherNames': ['anesthesiologist placed catheter'], 'description': 'presurgical sciatic catheter insertion', 'armGroupLabels': ['sciatic catheter']}, {'name': 'Stump catheter', 'type': 'PROCEDURE', 'otherNames': ['surgeon placed catheter'], 'description': 'intraoperative placed stump catheter', 'armGroupLabels': ['Stump catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1L8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Jason Wilson', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Andrew N Sawka, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}