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Comparison of Magnesium Sulphate vs Tramadol as Adjuvants in Intrathecal Bupivacaine for Postoperative Pain in TURP Patients

NCT07113782 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-11

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether adding magnesium sulfate or tramadol to intrathecal bupivacaine improves postoperative pain control and hemodynamic stability in adult male patients undergoing transurethral resection of the prostate (TURP).

The main questions this study aims to answer are:

Does the addition of magnesium sulfate or tramadol prolong the duration of postoperative analgesia compared to bupivacaine alone?

Does either adjuvant provide better intraoperative hemodynamic stability?

Researchers will compare two groups:

One group receiving magnesium sulfate plus bupivacaine

Another group receiving tramadol plus bupivacaine

to see which combination is more effective for pain control and hemodynamic outcomes.

Participants will:

Receive spinal anesthesia with either magnesium sulfate or tramadol added to bupivacaine.

Be monitored during surgery for heart rate, blood pressure, and other vital signs.

Be assessed after surgery for pain levels and time until first request for additional pain medication.

Conditions

  • Benign Prostatic Hyperplasia Postoperative Pain

Interventions

DRUG

1. Magnesium Sulphate 2. Tramadol

Magnesium Sulphate (Group M): 50 mg magnesium sulphate added to 12.5 mg of 0.5% hyperbaric bupivacaine, administered intrathecally. Tramadol (Group T): 25 mg tramadol added to 12.5 mg of 0.5% hyperbaric bupivacaine, administered intrathecally.

Sponsors & Collaborators

  • Armed Forces Institute of Urology, Rawalpindi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113782 on ClinicalTrials.gov