NCT07113782

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Armed Forces Institute of Urology, Rawalpindi · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This retrospective, randomized, double-blind clinical trial was conducted to compare the efficacy and safety of magnesium sulfate and tramadol as intrathecal adjuvants to hyperbaric bupivacaine in male patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia. The primary aim was to evaluate: The duration of postoperative analgesia, defined as the time from the completion of surgery to the patient's first request for rescue analgesia. Intraoperative hemodynamic stability, assessed by monitoring mean arterial pressure, heart rate, and the incidence of hypotension or bradycardia. A total of 60 adult male patients, aged 50 to 80 years, undergoing elective TURP were randomly allocated into two groups (30 patients each): Group M (Magnesium Group): Received 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg of magnesium sulfate intrathecally. Group T (Tramadol Group): Received 12.5 mg of 0.5% hyperbaric bupivacaine with 20 mg of tramadol intrathecally. All patients received spinal anesthesia at the L3-L4 or L4-L5 interspace under aseptic conditions. Intraoperative monitoring included ECG, non-invasive blood pressure, and pulse oximetry. Data on hemodynamic parameters were collected at regular intervals throughout the procedure. Primary Outcome Measures: Time to first postoperative analgesic request (in minutes) Mean arterial pressure and heart rate during the procedure Secondary Outcome Measures: Time to two-segment regression of the sensory block Incidence of adverse events including hypotension, bradycardia, nausea, vomiting, pruritus, urinary retention, and respiratory depression Blinding was maintained for both patients and the investigator recording postoperative outcomes. The study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Ethical approval was obtained from the Institutional Review Board of Armed Forces Institute of Urology (AFIU), Rawalpindi. Written informed consent was obtained from all participants prior to inclusion in the study. This trial was completed before registration and is being submitted retrospectively for transparency and publication compliance.

Conditions

• Benign Prostatic Hyperplasia Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: Pakistan