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

NCT07113782 | Completed Phase 4

• 1 other identifier: Trg 1/RB/2024/008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Magnesium sulphate; Tramadol; Intrathecal anesthesia; Bupivacaine; TURP; Postoperative pain; Hemodynamic stability

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia

  Time (in minutes) from administration of intrathecal drug to the first request for rescue analgesia (VAS ≥ 4).

  Up to 24 hours postoperatively

Study Arms (2)

Experimental - Group M (Magnesium Sulphate)

EXPERIMENTAL

Patients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg (0.1 mL) magnesium sulphate intrathecally. Intervention Name: Magnesium sulphate

Drug: 1. Magnesium Sulphate 2. Tramadol

Active Comparator - Group T (Tramadol)

ACTIVE COMPARATOR

Patients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 25 mg (0.5 mL) tramadol intrathecally. Intervention Name: Tramadol

Drug: 1. Magnesium Sulphate 2. Tramadol

Interventions

1. Magnesium Sulphate 2. Tramadol DRUG

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.

Active Comparator - Group T (Tramadol); Experimental - Group M (Magnesium Sulphate)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: The study involves TURP (Transurethral Resection of the Prostate), a procedure only performed in male patients.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 50 to 80 years
• Scheduled for elective transurethral resection of the prostate (TURP)
• American Society of Anesthesiologists (ASA) physical status I-II
• Provided written informed consent

You may not qualify if:

• Known allergy or hypersensitivity to bupivacaine, tramadol, or magnesium sulfate
• Contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site)
• History of chronic opioid use or substance abuse
• Severe hepatic, renal, or cardiac disease
• Neurological or psychiatric disorders affecting pain perception or reporting
• Participation in another clinical trial within the past 30 days

Sponsors & Collaborators

• Armed Forces Institute of Urology, Rawalpindi: lead

Study Sites (1)

AFIU

Rawalpindi, Punjab Province, 52250, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiologist

Model Details: This study used a randomized, controlled, parallel assignment interventional model in which participants were allocated into two groups. One group received intrathecal bupivacaine with magnesium sulphate, and the other received bupivacaine with tramadol. The interventions were administered once and compared for postoperative analgesia and hemodynamic stability without crossover.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 11, 2025
• Study Start: November 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

PA (1)