Comparison of Magnesium Sulphate vs Tramadol as Adjuvants in Intrathecal Bupivacaine for Postoperative Pain in TURP Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental - Group M (Magnesium Sulphate)
Patients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg (0.1 mL) magnesium sulphate intrathecally.
Intervention Name: Magnesium sulphate
干预措施: 1. Magnesium Sulphate 2. Tramadol (Drug)
Active Comparator - Group T (Tramadol)
Patients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 25 mg (0.5 mL) tramadol intrathecally.
Intervention Name: Tramadol
干预措施: 1. Magnesium Sulphate 2. Tramadol (Drug)
结局指标
主要结局
Duration of postoperative analgesia
时间窗: Up to 24 hours postoperatively
Time (in minutes) from administration of intrathecal drug to the first request for rescue analgesia (VAS ≥ 4).
次要结局
未报告次要终点
研究者
Jawad Ul Hassan
Anaesthesiologist
Armed Forces Institute of Urology, Rawalpindi