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临床试验/CTRI/2023/10/058224
CTRI/2023/10/058224尚未招募4 期

A comparative study between plain hyperbaric ropivacaine versus hyperbaric ropivacaine versus hyperbaric ropivacaine with nalbuphine under spinal anaesthesia in patients undergoing open inguinal hernia mesh repair

Rajarajeswari Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
To compare the effect of adding 0.8mg of Nalbuphine to 0.75% hyperbaric Ropivacaine vs plain 0.75% hyperbaric Ropivacaine for unilateral inguinal hernia open mesh repair surgeries under spinal anaesthesia.

研究概览

简要总结

Spinal anaesthesia is a safe and effective form of anaesthesia which can be used as analternative to general anaesthesia commonly in surgeries involving the lowerextremities and surgeries below umbilicus which provides anaesthesia,analgesia, motor and sensory blockade.

The primary aim of this study will be to compare the effect of adding nalbuphine to 0.75% hyperbaric ropivacaine versus plain 0.75% hyperbaric ropivacaine in unilateral inguinal hernia open mesh repair surgeries in terms of total duration of analgesia, onset and duration of both motor and sensory blockade.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • ASA I and II male patients.
  • Patients undergoing elective unilateral open inguinal hernia repair.

排除标准

  • Patient refusal.
  • Allergy to opioids and local anesthetics.
  • Morbidly obese patients.
  • Patients with coagulation abnormalities.
  • Previous spine surgeries and spinal deformities.
  • Mentally retarded patients.
  • Infection at the site of injection.
  • Patients having neurological abnormalities.

结局指标

主要结局

To compare the effect of adding 0.8mg of Nalbuphine to 0.75% hyperbaric Ropivacaine vs plain 0.75% hyperbaric Ropivacaine for unilateral inguinal hernia open mesh repair surgeries under spinal anaesthesia.

时间窗: Duration of analgesia in the first 24 hours post surgery

次要结局

  • To assess:(Time of onset of sensory and motor blockade.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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