Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-12 @ 4:33 AM
Study NCT ID:
NCT02782767
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-21', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS (Numerical Rating Score) in the two groups postoperatively', 'timeFrame': '24 hrs post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Upper Gastrointestinal Surgery', 'Post-operative Analgesia', 'Wound Infusion Catheter', 'Upper Midline Incision']}, 'descriptionModule': {'briefSummary': 'Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision\n\nExclusion Criteria:\n\n* Refusal to give consent.\n* Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)\n* Addiction to opioids, or alcohol, or history of any other substance abuse.\n* Allergy to local anaesthetic drugs.\n* Pregnancy.\n* Inability to communicate (e.g. known psychiatric disorders)'}, 'identificationModule': {'nctId': 'NCT02782767', 'briefTitle': 'Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery', 'orgStudyIdInfo': {'id': 'MDTG105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural catheter infusion', 'description': 'epidural catheter in the thoracic vertebra level to provide local anesthetic infusion', 'interventionNames': ['Other: Epidural infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Wound catheter infusion', 'description': 'A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion', 'interventionNames': ['Other: Wound catheter infusion']}], 'interventions': [{'name': 'Wound catheter infusion', 'type': 'OTHER', 'description': 'Wound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter.', 'armGroupLabels': ['Wound catheter infusion']}, {'name': 'Epidural infusion', 'type': 'OTHER', 'description': 'Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given', 'armGroupLabels': ['Epidural catheter infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'PGIMER', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Arun Raja Thangavel, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Junior Resident , MD Anaesthesia and Intensive care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Arun Raja T', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}