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临床试验/CTRI/2025/07/090451
CTRI/2025/07/090451尚未招募4 期

Comparison of pain scores with epidural and local anaesthesia in patients undergoing transforaminal endoscopic discectomy - A prospective randomised trial.

Dr Harshita Tiwari1 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17日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
A prospective randomised clinical trial to compare the analgesic efficacy of epidural and local anaesthesia in patients undergoing transforaminal endoscopic discectomy.

研究概览

简要总结

This study is an open labelled prospective randomized trial comparing the analgesic efficacy of epidural anaesthesia with 10 ml of 0.2 percent Bupivacaine  and local anaesthesia with 15 ml of 1 percent Lignocaine in patients undergoing transforaminal endoscopic discectomy. The study will be carried out in the Pain Division of Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi. The primary outcome will measure the extent of pain. The intensity of the pain variable will be recorded using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). Each patient will be asked to rate the perceived pain at pre procedure, during sheath placement, during inter vertebral disc removal, at the end of procedure and 1 week post operatively. The secondary outcomes will be to observe the number of doses of rescue analgesia (IV Fentanyl) needed , compare the complications , hemodynamic parameters, patient satisfaction score (as per Likerts scale) and disability (by Hi-ODI) between groups and to compare pre and post procedure CRP levels.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • ASA grade 1 and 2
  • Patients undergoing single level lumbar discectomy
  • Typical symptoms of nerve compression not relieved with conservative management and epidural steroid injections.

排除标准

  • Patients with sepsis
  • Patients with local site infection
  • Patients with allergy to local anaesthetics
  • Patients with coagulation abnormalities
  • Mentally unstable patients
  • Patients with hemodynamic instability
  • Severe systemic disease
  • Spinal abnormality.

结局指标

主要结局

A prospective randomised clinical trial to compare the analgesic efficacy of epidural and local anaesthesia in patients undergoing transforaminal endoscopic discectomy.

时间窗: Assessment done at pre procedure, during sheath placement phase, during inter vertebral disc removal phase, at the end of procedure and 1 week post operatively.

次要结局

  • 1. To compare the requirement of opioids between groups.(2. To compare the complications between groups.)

研究者

发起方
Dr Harshita Tiwari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Harshita Tiwari

Institute of Medical Sciences, Banaras Hindu University

研究点 (1)

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