Magnesium Sulfate in Addition to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Post-Operative Analgesia After Total Hip Arthroplasty

NCT ID: NCT06956950

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-11-30

Brief Summary

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:

• Does Magnesium sulphate lower Pain score (VAS) postoperatively.
• 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.

Participants will:

• Take with have ultrasound-guided transmuscular quadratus lumborum block after surgery using bupivacaine with Magnesium sulphate or with placebo
• Followed up 48 hours postoperatively to monitor pain score or any reported side effect.

Detailed Description

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.

Magnesium 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.

Conditions

Pain Score Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

bupivacaine /MgSo4

patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus MgSo4 after surgery

Group Type: ACTIVE_COMPARATOR

Bupivacaine + Magnesium sulfate

Intervention Type: DRUG

ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate

bupivacaine/saline

patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus saline after surgery

Group Type: ACTIVE_COMPARATOR

Bupivacaine + saline

Intervention Type: DRUG

ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline

Interventions

Bupivacaine + Magnesium sulfate

ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate

Intervention Type: DRUG

Bupivacaine + saline

ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• American Society of Anesthesiology (ASA) class I-III
• Undergoing hip arthroplasty .

Exclusion Criteria

• Patient refusal.
• Body mass index (BMI) > 40 Kg/m2.
• Allergy to local anesthetics or magnesium sulphate.
• coexisting coagulopathy.
• Local infection at puncture site.
• Severe renal impairment ( eGFR < 30 ml/min)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Mohammad Abdelsattar Elbagoury

Lecturer of anesthesia, surgical ICU and pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa Mohammad Abdelsattar Elbagoury, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer of anesthesia and surgical ICU and pain medicine

Locations

Faculty of medicine

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mostafa Mohammad Abdelsattar Elbagoury, MD

Role: CONTACT

mostafa.elbagoury@med.tanta.edu.eg

+201116297741

Dina Abdalla Elesawy Amer, MD

Role: CONTACT

denaa_abdallah@yahoo.com

+201066376552

Facility Contacts

Mohammed Hussain Mahmoud, professor

Role: primary

tanta_unv@unv.tanta.edu.eg

+20403317236

Other Identifiers

36264PR1128/3/25

Identifier Type: -

Identifier Source: org_study_id