Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-29 @ 8:45 AM
Study NCT ID:
NCT02225418
Status:
WITHDRAWN
Last Update Posted:
2015-07-22
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change of jobs', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score in sitting position', 'timeFrame': '1 hour', 'description': 'Numerical Rating Scale (NRS) score 1 hour after administration of TQL block'}], 'secondaryOutcomes': [{'measure': 'Pain score at rest', 'timeFrame': '15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour', 'description': 'NRS score after administration of TQL block at said time points'}, {'measure': 'Pain score at sitting position', 'timeFrame': '15 min 30 min 2 hour 3 hour 4 hour 5 hour', 'description': 'NRS score after administration of TQL block at said time points'}, {'measure': 'Total opioid consumption in PACU area', 'timeFrame': 'On average 3 hours', 'description': 'During stay in PACU area'}, {'measure': 'Opioid side effects (nausea, vomiting)', 'timeFrame': 'On average 3 hours', 'description': 'During stay in PACU area'}, {'measure': 'Length of stay in PACU area', 'timeFrame': 'On average 3 hours', 'description': 'Total time in PACU area'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopic', 'Cholecystectomy', 'Postoperative', 'Pain', 'Quadratus lumborum', 'Ultrasound'], 'conditions': ['Cholecystitis', 'Pain']}, 'descriptionModule': {'briefSummary': 'The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.\n\nThe trial will compare active TQL block versus placebo TQL block after said operation.\n\nThe hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for elective laparoscopic cholecystectomy\n* received oral and written information about the trial\n* American Society of Anaethesiologists (ASA) classification 1-3\n* NRS score \\> 3 upon arrival at the PACU area\n\nExclusion Criteria:\n\n* Cannot cooperate\n* Does not speak or understand Danish\n* Allergy towards drugs used in the trial\n* Large daily consumption of opioids\n* Known alcohol og medicin abuse\n* Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02225418', 'acronym': 'TQL', 'briefTitle': 'Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'BBH-TQL-LC'}, 'secondaryIdInfos': [{'id': '2013-001364-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Placebo TQL block', 'description': '30 ml single shot TQL block with saline 0,9%', 'interventionNames': ['Drug: saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active TQL block', 'description': '30 ml single shot TQL block with ropivacaine 0,75%', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['naropin'], 'armGroupLabels': ['Active TQL block']}, {'name': 'saline', 'type': 'DRUG', 'armGroupLabels': ['Placebo TQL block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400 NV', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jens Børglum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital Bispebjerg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Borglum Neimann', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bispebjerg Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jens Borglum Neimann', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}