跳至主要内容
临床试验/CTRI/2016/12/007577
CTRI/2016/12/007577已完成不适用

Comparison of analgesic efficacy ofepidural analgesia with continuous transversusabdominis plane block in renal transplant recipients

PGIMER1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2014年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
PGIMER
入组人数
62
试验地点
1
主要终点
Numerical Pain rating scale score postoperatively

研究概览

简要总结

Although continuous TAPblock has been compared with epidural analgesia in laparoscopic surgeries, tothe best of our knowledge a study directly comparing the technique withepidural analgesia has not been performed in renal transplantrecipients. The existing study was designed to directly comparecontinuous TAP block with continuous patient controlled epidural blockade todetermine whether TAP block can provide a useful alternative to epiduralanalgesia in this subset of patients.

The studyhypothesizes that transversus abdominis plane block is a non inferior analgesictechnique to continuous epidural analgesia in renal transplant recipients.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with end stage renal disease scheduled to undergo live donor renal transplant.

排除标准

  • 1.Refusal to give consent.
  • 2.Derangements of coagulation profile contraindicating the use of epidural anaesthesia (INR of ≥1.3 will be considered a cut-off for the study).
  • 3.Addiction to opioids, or alcohol, or history of any other substance abuse.
  • 4.Allergy to local anaesthetic drugs.
  • 5.Extension of surgical incision lateral to anterior axillary line or above T8 dermatome.
  • 6.Inability to communicate (e.g. known psychiatric disorders).
  • 7.Accidental complications such as dural puncture or peritoneal breach.

结局指标

主要结局

Numerical Pain rating scale score postoperatively

时间窗: Numerical Pain rating scale score at 0, 1, 2, 4, 6, 12, 24 hours postoperatively

次要结局

  • Requirement of postoperative opioid (fentanyl) in the first 24 hours postoperatively(24 hours postoperatively)
  • Patient satisfaction with the analgesia regimen.(24 hours postoperatively)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital

研究点 (1)

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