Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 9:24 PM
Study NCT ID:
NCT04541732
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2020-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blind study'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative 24 hours cumulative rescue morphine consumption', 'timeFrame': 'For 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'The duration of postoperative analgesia', 'timeFrame': 'For 24 hours after surgery', 'description': 'time from performing epidural or quadratus lumborum block till the time for the first rescue morphine request'}, {'measure': 'Postoperative pain score at rest', 'timeFrame': 'For 24 hours after surgery', 'description': 'Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)'}, {'measure': 'Postoperative pain score on movement', 'timeFrame': 'For 24 hours after surgery', 'description': 'Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)'}, {'measure': 'Postoperative pain score on cough', 'timeFrame': 'For 24 hours after surgery', 'description': 'Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'For 28 hours after induction of anesthesia'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'For 28 hours after induction of anesthesia'}, {'measure': 'Mean blood pressure', 'timeFrame': 'For 28 hours after induction of anesthesia'}, {'measure': 'Heart rate', 'timeFrame': 'For 28 hours after induction of anesthesia'}, {'measure': 'Degree of postoperative nausea and vomiting', 'timeFrame': 'For 24 hours after surgery', 'description': 'Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3). The number of vomiting episodes and the number of antiemetics received will be recorded'}, {'measure': 'Pruritis', 'timeFrame': 'For 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elective Major Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried.\n\nEpidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility. However, it is not without complications.\n\nQuadratus lumborum block is an ultrasound-guided block that provides patients with both visceral and somatic blockade. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for analgesia after major abdominal surgeries.', 'detailedDescription': 'The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus lumborum block as a postoperative analgesic modality after major abdominal surgery in comparison to epidural block and its effects on total rescue analgesic requirements in the 1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative and postoperative hemodynamics and postoperative opioid-related side effects.\n\nUnder complete aseptic conditions, the patients will receive either thoracic epidural block or bilateral ultrasound-guided quadratus lumborum block after induction of general anaesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-III\n\nExclusion Criteria:\n\n* Patient's refusal\n* Significant cardiac, disease.\n* Significant hepatic disease.\n* Significant renal disease (serum creatinine ˃ 1.5 mg/dl).\n* Patients with drug abuse\n* Allergy to study medications\n* Mental disease\n* Communication barrier.\n* Coagulopathy.\n* Local skin infection"}, 'identificationModule': {'nctId': 'NCT04541732', 'briefTitle': 'Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Ultra-sound Guided Bilateral Quadratus Lumborum Block Versus Epidural Block for Postoperative Analgesia After Major Abdominal Surgeries.', 'orgStudyIdInfo': {'id': 'MS ∕18.06.187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracic epidural block', 'description': 'Patients will receive thoracic epidural block following induction of general anaesthesia', 'interventionNames': ['Other: Thoracic epidural block', 'Drug: Induction of general anaesthesia with propofol', 'Drug: Muscle Relaxant', 'Drug: Maintenance of general anaesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral quadratus lumborum block', 'description': 'Patients will receive Ultrasound-guided bilateral quadratus lumborum block following induction of general anaesthesia', 'interventionNames': ['Other: Ultrasound-guided bilateral quadratus lumborum block', 'Drug: Induction of general anaesthesia with propofol', 'Drug: Muscle Relaxant', 'Drug: Maintenance of general anaesthesia']}], 'interventions': [{'name': 'Thoracic epidural block', 'type': 'OTHER', 'description': 'Patients who will be subjected to epidural block will be placed in the lateral position then, after sterilization of the skin, 21 G spinal needle will be inserted at T9-T11 intervertebral spaces. The epidural space will be located using the loss of resistance to air technique and a mixture of bupivacaine 0.25% + 50 μ fentanyl targeting T6 level will be injected following induction of general anaesthesia.', 'armGroupLabels': ['Thoracic epidural block']}, {'name': 'Ultrasound-guided bilateral quadratus lumborum block', 'type': 'OTHER', 'description': 'Patients who will be subjected to major abdominal surgeries will be placed in a supine position with a pillow under their side to obtain an appropriate view of quadratus lumborum muscle. After sterilization of the skin and ultrasound-guided identification of the quadratus lumborum muscle, 20 ml bupivacaine 0.25% + 25μ fentanyl will be injected on each side following induction of general anaesthesia', 'armGroupLabels': ['Bilateral quadratus lumborum block']}, {'name': 'Induction of general anaesthesia with propofol', 'type': 'DRUG', 'description': 'propofol: 1.5-2.5mg/Kg', 'armGroupLabels': ['Bilateral quadratus lumborum block', 'Thoracic epidural block']}, {'name': 'Muscle Relaxant', 'type': 'DRUG', 'description': 'Atracurium : 0.5mg/Kg.', 'armGroupLabels': ['Bilateral quadratus lumborum block', 'Thoracic epidural block']}, {'name': 'Maintenance of general anaesthesia', 'type': 'DRUG', 'description': 'Sevoflurane 0.7-1.5 MAC in 40% oxygen', 'armGroupLabels': ['Bilateral quadratus lumborum block', 'Thoracic epidural block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mohammed A Ghanem', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohammed A Ghanem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor'}, {'name': 'Mona A Hasheesh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}