CTRI/2025/04/086029尚未招募不适用
Comparison of Magnesium Sulphate versus Gabapentin for post-operative analgesia in patients undergoing complex lumbosacral spinal fixation surgery: A Prospective, Randomized, Double-blinded, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Post-operative pain assessment using Numeric Rating Scale for surgical site pain and leg pain (radiculopathy)(NRS)
研究概览
简要总结
This study aims to compare the efficacy of Magnesium sulphate and gabapentin, in postoperative analgesia following elective lumbosacral spinal fixation surgery. Patients will be randomized into three groups and allocation concealment will be done using sequentially numbered opaque sealed envelope method. This study will provide insights into the comparative effectiveness of magnesium sulphate and gabapentin in optimizing analgesia and recovery following complex spinal fixation surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) grade I-II patients undergoing elective lumbosacral spinal fixation surgery (non traumatic spondylopathy) involving two or more levels.
排除标准
- •Patient refusal Patient with known hypersensitivity to either drug Patient with neuromuscular disease like Myasthenia Gravis Patients already on Capsule Gabapentin Pregnancy Patients with pre-existing significant cardiac, respiratory, hepatic, renal disease Patients lost to/not willing to follow up.
结局指标
主要结局
Post-operative pain assessment using Numeric Rating Scale for surgical site pain and leg pain (radiculopathy)(NRS)
时间窗: At regular intervals during first 24 hour postoperatively
次要结局
- Intra-operative haemodynamic changes(During the surgery at regular intervals)
- Opioid consumption(During surgery and in the first 24 hours after surgery)
- time for Requirement of first rescue analgesia(In the first 24 hours after surgery)
- Adverse effects of study drugs if any(Immediate and delayed)
- Time taken for first ambulation(After surgery (in hours))
- Number of hospitalisation days(Post-operative days)
- Quality of life assessment using EuroQoL questionnaire(At the time of hospital discharge and 30)
研究者
Dr Tanzim Akram
All India Institute of Medical Sciences (AIIMS), Rishikesh
研究点 (1)
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