Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 6:12 AM
Study NCT ID:
NCT01423292
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2011-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-08-24', 'lastUpdatePostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score during cough', 'timeFrame': '24hr after TAP block', 'description': 'pain score during cough at 24 hours after TAP block (using visual analog scale)'}], 'secondaryOutcomes': [{'measure': 'pain score during bed rest and ambulation at ward, dosage of used opioid, nausea score, sedation score, days of hospitalization, start day of diet, reinsertion rate of urinary catheter, satisfaction measurement of pain control, life of quality', 'timeFrame': '24hr, 48hr, 72hr after TAP block'}]}, 'conditionsModule': {'conditions': ['Laparoscopic Colecctomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 20\\~80\n* undergoing laparoscopic colectomy\n\nExclusion Criteria:\n\n* allergic history to local anesthesitcs\n* tolerance to opioid\n* cannot use IV-PCA\n* previous abdominal surgery\n* intestinal obstruction\n* emergency'}, 'identificationModule': {'nctId': 'NCT01423292', 'briefTitle': 'Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'orgStudyIdInfo': {'id': 'NCCCTS-11-557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'an odd numbered patients', 'description': 'TAP block with local anesthetics', 'interventionNames': ['Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block', 'Drug: bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'an even numbered patients', 'description': 'TAP block without local anesthetics', 'interventionNames': ['Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block', 'Drug: Placebo']}], 'interventions': [{'name': 'Ultrasound Guided Transversus Abdominis Plane (TAP) Block', 'type': 'PROCEDURE', 'description': 'Ultrasound Guided Transversus Abdominis Plane (TAP) Block', 'armGroupLabels': ['an even numbered patients', 'an odd numbered patients']}, {'name': 'bupivacaine', 'type': 'DRUG', 'description': '0.25 bupivacaine 30ml (15ml on each side)', 'armGroupLabels': ['an odd numbered patients']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['an even numbered patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Center for Colorectal Cancer', 'investigatorFullName': 'Ji Won Park', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}