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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07113782
Enrollment
60
Registered
2025-08-11
Start date
2024-11-01
Completion date
2025-04-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia Postoperative Pain

Keywords

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

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.

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.

Interventions

DRUG1. 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

Armed Forces Institute of Urology, Rawalpindi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative analgesiaUp to 24 hours postoperativelyTime (in minutes) from administration of intrathecal drug to the first request for rescue analgesia (VAS ≥ 4).

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026