Magnesium Sulfate in Addition to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Post-Operative Analgesia After Total Hip Arthroplasty (Mgso4)

Efficacy of Adding Magnesium Sulfate to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Patients Underdoing Hip Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Score Reduction
• Intervention / Treatment: Drug: Bupivacaine + Magnesium sulfate; Drug: Bupivacaine + saline

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Mostafa Mohammad Abdelsattar Elbagoury, MD; Phone Number: +201116297741; Email: mostafa.elbagoury@med.tanta.edu.eg
• Study Contact Backup: Name: Dina Abdalla Elesawy Amer, MD; Phone Number: +201066376552; Email: denaa_abdallah@yahoo.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Faculty of medicine
      • Contact: Mohammed Hussain Mahmoud, professor; Phone Number: +20403317236; Email: tanta_unv@unv.tanta.edu.eg
      • Principal Investigator: Mostafa Mohammad Abdelsattar Elbagoury, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine /MgSo4; patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus MgSo4 after surgery	Drug: Bupivacaine + Magnesium sulfate; ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate
Active Comparator: bupivacaine/saline; patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus saline after surgery	Drug: Bupivacaine + saline; ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postopeative pain Score	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.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	total morphine consumption after surgery	48 hours postoperatively
Time to first rescue analgsic request		48 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mostafa Mohammad Abdelsattar Elbagoury, MD, lecturer of anesthesia and surgical ICU and pain medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): October 9, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Reproductive Control Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Anti-Arrhythmia Agents; Membrane Transport Modulators; Anticonvulsants; Calcium Channel Blockers; Tocolytic Agents; Bupivacaine; Magnesium Sulfate
• Other Study ID Numbers: 36264PR1128/3/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No