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Recruiting NCT06956950

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

Phase II / Phase III Interventional Pain Score Reduction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine + Magnesium sulfate, Bupivacaine + saline.
Who it may be relevant to
Registry conditions: Pain Score Reduction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Bupivacaine + Magnesium sulfate
    ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate
  • Drug Bupivacaine + saline
    ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline

Primary outcome measures

  • postopeative pain Score [Time frame: 48 hours postoperatively]
Secondary outcome measures (2)
  • Total opioid consumption [Time frame: 48 hours postoperatively]
  • Time to first rescue analgsic request [Time frame: 48 hours postoperatively]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of medicine — Tanta

Identifiers

NCT: NCT06956950 · 36264PR1128/3/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗