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

NCT06956950 | Recruiting Phase 2 DMC

• 1 other identifier: 36264PR1128/3/25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Score Reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total opioid consumption

  48 hours postoperatively

• Time to first rescue analgsic request

  48 hours postoperatively

Study Arms (2)

bupivacaine /MgSo4

ACTIVE COMPARATOR

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

Drug: Bupivacaine + Magnesium sulfate

bupivacaine/saline

ACTIVE COMPARATOR

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

Drug: Bupivacaine + saline

Interventions

Bupivacaine + Magnesium sulfate DRUG

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

bupivacaine /MgSo4

Bupivacaine + saline DRUG

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

bupivacaine/saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Mostafa Mohammad Abdelsattar Elbagoury, MD

  lecturer of anesthesia and surgical ICU and pain medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Mohammad Abdelsattar Elbagoury, MD

CONTACT

+201116297741; mostafa.elbagoury@med.tanta.edu.eg

Dina Abdalla Elesawy Amer, MD

CONTACT

+201066376552; denaa_abdallah@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, surgical ICU and pain medicine

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

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion: October 9, 2025
• Study Completion: November 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)