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临床试验/CTRI/2024/09/073892
CTRI/2024/09/073892尚未招募不适用

A comparative study of oral gabapentin versus oral pregabalin in acute post-operative pain management in patients undergoing urological procedures under sub-arachnoid block.

Sapthagiri Institute of Medical Sciences and Research Institute1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
VAS score

研究概览

简要总结

After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent.

Demographic details of the patients will be recorded as per the case record form.

After a thorough pre-operative evaluation, visual analogue score (VAS) is explained to the patient. On the day of surgery, two hours prior to the procedure, patients are pre-medicated with Tab. Pantoprazole 40mg. Patients are randomly allocated into two groups based on computer generated random number table. The patients are unaware as to which group they belong.

Group A receive T.  Pregabalin 150mg and Group B receive T. Gabapentin 600mg. After shifting the patient to operating room, sub-arachnoid block is given with Inj. Bupivacaine heavy (0.5%) at a dose of 0.3mg/kg body weight with maximum dose limited to 20mg and the level was assessed.After surgery, all the patients received IV Paracetamol 1 gram and are shifted to the recovery room. All patients are given Inj. Tramadol 50mg as rescue analgesia, once VAS exceeds 4. The patients are subsequently shifted to ward. Post-operatively VAS score is assessed at 0,2,4,6 and 12 hours after surgery. Total amount of analgesic administered is recorded. Any adverse events like giddiness, nausea, vomiting in the first 24 hours of post-operative period is noted.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give written informed consent.
  • Patients undergoing urological procedure.

排除标准

  • 3 & above.
  • Patients with known allergy to pregabalin, history of intake of NSAIDs within 48 hours of surgery, coagulation abnormalities.
  • Patients on anti-coagulant and anti-platelet medications.

结局指标

主要结局

VAS score

时间窗: VAS score assessed at baseline, 2, 4, 6 and 12 hours after procedure.

次要结局

未报告次要终点

研究者

发起方
Sapthagiri Institute of Medical Sciences and Research Institute
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Kavyashree M Arun

Sapthagiri Institute of Medical Sciences and Research Centre

研究点 (1)

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