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

Phase 2

Recruiting

• Conditions: Pain Score Reduction
• Interventions: Drug: Bupivacaine + Magnesium sulfate; Drug: Bupivacaine + saline

• Registration Number: NCT06956950
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Posted: 2025-05-04
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-10-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine /MgSo4	Bupivacaine + Magnesium sulfate	patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus MgSo4 after surgery
bupivacaine/saline	Bupivacaine + saline	patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus saline after surgery

Primary Outcome Measures

Name	Time	Method
postopeative pain Score	48 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	48 hours postoperatively	total morphine consumption after surgery
Time to first rescue analgsic request	48 hours postoperatively

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Tanta, El-Gharbia, Egypt