A comparative study of Intrathecal Fentanyl and Nalbuphine as an adjuvant to hyperbaric Bupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries:A prospective double blinded randomized control study

Subhaprada satapathy1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年12月1日最近更新: 2021年5月1日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 100
试验地点: 1
主要终点: To compare the duration of effective analgesia between the two drugs(time from intrathecal injection till the requirement of first rescue analgesic)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Post operative pain control is a major concern because spinal anaesthesia using only local anaesthetics is associated with relatively shorter duration of action and thus early analgesic intervention is needed in post-operative period. There are very few studies which have compared efficacy of intrathecal Fentanyl and Nalbuphine as adjuvants to hyperbaric Bupivacaine in lower limb surgeries,therefore this present study is planned with the aim of comparing the analgesic effect & duration of analgesia provided by intathecal Fentanyl and Nalbuphine.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
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

•1.Adults in the age group of 18-65 years 2.ASA I or II 3.Elective lower limb surgeries.

排除标准

•1.Body mass index â‰¥
•2.Height less than 155 cm.
•3.Contraindications to spinal anaesthesia(patient refusal,coagulation disorder, infection at puncture site,increased intracranial tension, haemodynamic instability, spinal deformities,known history of allergy to the study drugs).
•4.Patients on hypnotics,antipsychotics,tranquilizers or other CNS depressants.
•5.Patients with history of adverse reaction to opioids.
•6.Pregnancy.

结局指标

主要结局

To compare the duration of effective analgesia between the two drugs(time from intrathecal injection till the requirement of first rescue analgesic)

时间窗: 1.5years

次要结局

1.Intraoperative haemodynamic parameters.(2.Post operative VAS)

研究者

发起方

Subhaprada satapathy

申办方类型

Other [self]

研究点 (1)

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