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临床试验/NCT07389551
NCT07389551已完成不适用

Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic in Patients Undergoing Orthopedic Surgeries Under Spinal Anesthesia

Muhammad Aamir Latif1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
1
主要终点
Pain severity

研究概览

简要总结

There are extensive gaps in the local data considering pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia. Therefore, the current study was planned with the objective of comparing pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia.

详细描述

Since postoperative pain in orthopedic surgery, whether neuropathic or nociceptive, presents a significant challenge for both surgeons and patients, knowing the more effective gabapentinoid as a pre-emptive analgesic would help clinicians to offer prolonged timing of first rescue analgesia and less opioid consumption.

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
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Either gender
  • Aged 20-60 years
  • Undergoing lower limb orthopedic surgeries under spinal anesthesia

排除标准

  • Patients with a previous history of spine interventions, including surgery or injections (transforaminal, epidural, or facetal) for pain relief
  • Patients under any sort of pain modulation therapy, like transcutaneous electrical nerve stimulation
  • Patients had a long-term history of any analgesia use
  • Those with psychiatric disorders, alcohol/drug dependence, hepatic, renal, cardiac, or pulmonary abnormalities,
  • With a history of allergies to gabapentinoids

研究组 & 干预措施

Group-G

Experimental

Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.

干预措施: Gabapentin (Drug)

Group-P

Experimental

Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia

干预措施: Pregabalin (Drug)

结局指标

主要结局

Pain severity

时间窗: 24 hours

The severity of pain was analyzed on the visual analogue scale (VAS), with a lower score labelling the effectiveness of the treatment.

Analgesia duration

时间窗: 24 hours

The duration of analgesia was measured from awakening to the need of rescue analgesia, when a pain score was more than 3 on VAS.

次要结局

未报告次要终点

研究者

发起方
Muhammad Aamir Latif
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Aamir Latif

Research Consultant

RESnTEC, Institute of Research

研究点 (1)

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