A Phase 4 interventional study of 1. Magnesium Sulphate 2. Tramadol in Benign Prostatic Hyperplasia Postoperative Pain, sponsored by Armed Forces Institute of Urology, Rawalpindi. Completed at 1 site in Pakistan. Open to male participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Armed Forces Institute of Urology, Rawalpindi · Phase 4, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Armed Forces Institute of Urology, Rawalpindi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Duration of postoperative analgesia
Time (in minutes) from administration of intrathecal drug to the first request for rescue analgesia (VAS ≥ 4).
Time frame: Up to 24 hours postoperatively
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Armed Forces Institute of Urology, Rawalpindi