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临床试验/CTRI/2025/07/090700
CTRI/2025/07/090700尚未招募2/3 期

A comparative study of Epidural Nalbuphine vs Tramadol as an adjuvant to 0.2% Ropivaciane for post operative pain relief in unilateral total knee replacement surgeries.

Rukmani Birla hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Post operative pain assessment

研究概览

简要总结

This study is a randomized control double blind study , single centre trial comparing the efficacy of Nalbuphine 0.2mg/ml and Tramadol 2mg/ml as an adjuvant to 0.2% Ropivacaine epidurally for post-op analgesia in unilateral total knee replacement surgery. Total sample size is 50 patients divided in two equal groups. The primary outcome measures will be difference in VAS score between groups at 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours. The secondary outcomes will be patient satisfaction, post-op nausea and vomiting and requirement of breakthrough analgesia.

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
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Giving the consent ASA grade 1 and 2 Age groups 45-70 years.

排除标准

  • ASA 3/4 Refusal of consent Bleeding diathesis Contraindication to epidural anaesthesia Pregnancy and lactating mother.

结局指标

主要结局

Post operative pain assessment

时间窗: 30 mins 1 hr 2 hr 4 hr 6 hr 12 hr 24 hr

次要结局

  • PONV , patient satisfaction(30 mins 1 hr 2 hr 4 hr 6 hr 12 hr 24 hr)

研究者

发起方
Rukmani Birla hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Harshita jain

Rukmani Birla hospital

研究点 (1)

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