Comparison of Mean Post-Operative Pain Score & Duration of Analgesia Following Bupivacaine Alone Versus Bupivacaine Plus Tramadol in Patients Undergoing Lower Limb Surgeries
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
- Post operative analgesia
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of bupivacaine alone versus bupivacaine combined with tramadol for postoperative analgesia in patients undergoing lower limb surgeries under spinal anesthesia. A total of 60 patients, aged 18-70 years and classified as ASA I or II, were included and randomly divided into two groups of 30 patients each. The bupivacaine group received 15 mg of 0.75% hyperbaric bupivacaine, while the combination group received 15 mg bupivacaine with 15 mg tramadol. Postoperative pain was assessed using the Visual Analogue Scale (VAS), and the duration of analgesia was recorded as the time from administration of the drug until the patient developed a VAS score of ≥3, indicating the need for rescue analgesia. The findings suggested that adding tramadol to bupivacaine provided better and longer-lasting postoperative pain relief compared with bupivacaine alone.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Genders
- •Age between 17 to 80 years
- •ASA 1 and 2
- •Lower Limb Surgeries undergoing Spinal anesthesia
排除标准
- •Patients with
- •Significant comorbid conditions falling under ASA class ≥III (Appendix).
- •BMI ≥35 Kg/m2 (calculated by diving weight in kilograms by height in meter square)
- •Diabetes (fasting blood sugar ≥110mg/dl) & Cancer (as per history and clinical record)
- •Previous lower limb surgery in the preceding 6 months period (as per history and clinical record)
- •Patients allergic to study drugs, infection at the site of injection and neurological deficit
研究组 & 干预措施
Bupivacaine
15mg of 0.75% Hyperbaric Bupivacaine
干预措施: Bupivacain only (Drug)
Bupivacaine plus Tramadol
15mg of 0.75% Hyperbaric Bupivacaine plus 15mg Tramadol
干预措施: bupivacain-tramadol (Drug)
结局指标
主要结局
Post operative analgesia
时间窗: 12 hours and 24 hours after administration of drugs
Pain score assessed using Visual Analogue Score ( 0 to 10)
Time to first rescue analgesia
时间窗: Variable ( Maximum 24 Hours)
Time duration from drug administration to the first subjective request of patient for rescue analgesia.
次要结局
未报告次要终点
研究者
Dr. Affifa Saleem
Post graduate trainee
Farooq Hospital / Akhtar Saeed Medical college Rawalpindi