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NCT Number: NCT06956950

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of medicine

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohammed Hussain Mahmoud, professor

CONTACT

[email protected]

+20403317236

Mostafa Mohammad Abdelsattar Elbagoury, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bupivacaine + Magnesium sulfate

Drug

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

Bupivacaine + saline

Drug

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

Primary outcomes

  1. postopeative pain Score

    Time frame: 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 outcomes

  1. Total opioid consumption

    Time frame: 48 hours postoperatively

    total morphine consumption after surgery

  2. Time to first rescue analgsic request

    Time frame: 48 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Abdalla Elesawy Amer, MD

CONTACT

[email protected]

+201066376552

Mostafa Mohammad Abdelsattar Elbagoury, MD

CONTACT

[email protected]

+201116297741

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: Mgso4

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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