Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-04 @ 1:59 PM
Study NCT ID:
NCT03956966
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2019-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, double blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-29', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-18', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for first request to rescue analgesia', 'timeFrame': '24 hours', 'description': 'Time for the first request to rescue analgesia (in minutes)'}], 'secondaryOutcomes': [{'measure': 'postoperative Nalbuphine', 'timeFrame': '24 hours after surgery', 'description': 'Cumulative postoperative Nalbuphine consumption (total dose given in milligrams)'}, {'measure': 'intraoperative fentanyl', 'timeFrame': 'For 4 hours after start of anaesthesia', 'description': 'Cumulative intraoperative fentanyl consumption (total dose given in micrograms)'}, {'measure': 'Postoperative pain severity will be assessed using VAPS', 'timeFrame': 'For 24 hours after surgery', 'description': 'The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAPS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain'}, {'measure': 'side effects', 'timeFrame': 'For 24 hours after surgery', 'description': 'Incidence of postoperative nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quadratus Lumborum Block', 'Laparoscopic Cholecystectomy', 'dexamethasone'], 'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.\n\nBecause postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.', 'detailedDescription': 'The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side.\n\nThe following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Physical Status I or II\n* Elective laparoscopic Cholecystectomy\n\nExclusion Criteria:\n\n* Patient refusal.\n* Hematological diseases\n* Bleeding disorders.\n* Coagulation abnormality.\n* Psychiatric diseases.\n* Local skin infection\n* Sepsis at site of the block.\n* Known intolerance to the study drugs.\n* Body Mass Index \\> 40 Kg/m2.\n* Emergency laparoscopic cholecystectomy\n* If laparoscopic procedure converted to open.'}, 'identificationModule': {'nctId': 'NCT03956966', 'briefTitle': 'Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '88-11/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'bilateral quadratus lumborum block using 0.9% normal saline', 'interventionNames': ['Drug: TQL block with saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%', 'interventionNames': ['Drug: TQL block with Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine and dexamethasone', 'description': 'bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone', 'interventionNames': ['Drug: TQL block with Bupivacaine and dexamethasone']}], 'interventions': [{'name': 'TQL block with saline', 'type': 'DRUG', 'otherNames': ['C Group'], 'description': 'drug: saline 21 ml 0.9% normal saline administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.\n\nDrug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.\n\nDrug: Ketorolac analgesia In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than3.\n\nDevice: ultrasound-guided nerve block Transmuscular quadratus lumborum block, ultrasound-guided', 'armGroupLabels': ['saline']}, {'name': 'TQL block with Bupivacaine', 'type': 'DRUG', 'otherNames': ['B Group'], 'description': 'Drug: saline\n\n1mL 0.9% normal saline administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.\n\nDrug: Paracetamol 15 mg.kg will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given to all cases every 8 hours.\n\nDrug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.\n\nDevice: ultrasound-guided nerve block Transmuscular quadratus lumborum block', 'armGroupLabels': ['Bupivacaine']}, {'name': 'TQL block with Bupivacaine and dexamethasone', 'type': 'DRUG', 'otherNames': ['D Group'], 'description': 'Drug: dexamethasone\n\n1 mL dexamethasone "4mg" administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in MBP or HR of more than 20% of baseline for longer than 5 minutes.\n\nDrug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.\n\nDrug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.\n\nDevice: ultrasound-guided nerve block Transmuscular quadratus lumborum block', 'armGroupLabels': ['Bupivacaine and dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61519', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minya University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Haidy S Mansour, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'assistant professor of Anesthesia and Surgical Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'haidy salah mansour', 'investigatorAffiliation': 'Minia University'}}}}