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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The study involves TURP (Transurethral Resection of the Prostate), a procedure only performed in male patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AFIU | Rawalpindi | Punjab Province | 52250 | Pakistan |
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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.
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|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
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