Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 5:11 PM
Study NCT ID:
NCT06956950
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate in Addition to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Post-Operative Analgesia After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'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': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postopeative pain Score', 'timeFrame': '48 hours postoperatively', 'description': 'The degree of pain will be assessed after surgery by Visual Analogue Score (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 6 , 12 , 24 , 48 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '48 hours postoperatively', 'description': 'total morphine consumption after surgery'}, {'measure': 'Time to first rescue analgsic request', 'timeFrame': '48 hours postoperatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Score Reduction']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to evaluate the efficacy of adding magnesium sulfate to bupivacaine in ultrasound-guided transmuscular quadratus lumborum block for postoperative analgesia in adult patients underdoing hip arthroplasty. The main questions it aims to answer are:\n\n* Does Magnesium sulphate lower Pain score (VAS) postoperatively.\n* Does Magnesium sulphate lowerTotal opioid consumption postoperatively. and What side effects do participants have when taking Magnesium sulphate? Researchers will compare Magnesium sulphate to a placebo (a look-alike substance that contains no drug) to see if Magnesium sulphate works to lower pain score.\n\nParticipants will:\n\n* Take with have ultrasound-guided transmuscular quadratus lumborum block after surgery using bupivacaine with Magnesium sulphate or with placebo\n* Followed up 48 hours postoperatively to monitor pain score or any reported side effect.', 'detailedDescription': 'The quadratus lumborum block (QLB) is an abdominal wall fascial block plane block described for providing perioperative analgesia for abdominal, hip and lower limb surgeries . Opioid-sparing analgesic treatments for hip arthroplasty such as lumbar plexus and femoral nerve blocks, are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently provide adequate pain relief. Quadratus lumborum (QL) block is a relatively new truncal regional block technique that provides effective pain control after upper and lower abdominal surgeries. ersalis fascia laterally. The anterior QL block was also classified as transmuscular approach (in between QL and PM muscles) in earlier studies . Local anesthetic injected between the QL muscle and anterior layer of the thoracolumbar fascia can potentially spread to the thoracic paravertebral (PVB) space.\n\nMagnesium plays an important role in the physiological function of the human body. A large number of studies have reported the safetyand effectiveness of adding magnesium sulfate in various regional anesthesia techniques . Therefore, this prospective randomized controlled study to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* American Society of Anesthesiology (ASA) class I-III\n* Undergoing hip arthroplasty .\n\nExclusion Criteria:\n\n* Patient refusal.\n* Body mass index (BMI) \\> 40 Kg/m2.\n* Allergy to local anesthetics or magnesium sulphate.\n* coexisting coagulopathy.\n* Local infection at puncture site.\n* Severe renal impairment ( eGFR \\< 30 ml/min)'}, 'identificationModule': {'nctId': 'NCT06956950', 'acronym': 'Mgso4', 'briefTitle': 'Magnesium Sulfate in Addition to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Post-Operative Analgesia After Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Efficacy of Adding Magnesium Sulfate to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Patients Underdoing Hip Arthroplasty', 'orgStudyIdInfo': {'id': '36264PR1128/3/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine /MgSo4', 'description': 'patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus MgSo4 after surgery', 'interventionNames': ['Drug: Bupivacaine + Magnesium sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine/saline', 'description': 'patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus saline after surgery', 'interventionNames': ['Drug: Bupivacaine + saline']}], 'interventions': [{'name': 'Bupivacaine + Magnesium sulfate', 'type': 'DRUG', 'description': 'ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate', 'armGroupLabels': ['bupivacaine /MgSo4']}, {'name': 'Bupivacaine + saline', 'type': 'DRUG', 'description': 'ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline', 'armGroupLabels': ['bupivacaine/saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Hussain Mahmoud, professor', 'role': 'CONTACT', 'email': 'tanta_unv@unv.tanta.edu.eg', 'phone': '+20403317236'}, {'name': 'Mostafa Mohammad Abdelsattar Elbagoury, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mostafa Mohammad Abdelsattar Elbagoury, MD', 'role': 'CONTACT', 'email': 'mostafa.elbagoury@med.tanta.edu.eg', 'phone': '+201116297741'}, {'name': 'Dina Abdalla Elesawy Amer, MD', 'role': 'CONTACT', 'email': 'denaa_abdallah@yahoo.com', 'phone': '+201066376552'}], 'overallOfficials': [{'name': 'Mostafa Mohammad Abdelsattar Elbagoury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer of anesthesia and surgical ICU and pain medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia, surgical ICU and pain medicine', 'investigatorFullName': 'Mostafa Mohammad Abdelsattar Elbagoury', 'investigatorAffiliation': 'Tanta University'}}}}