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临床试验/CTRI/2025/08/092513
CTRI/2025/08/092513尚未招募3 期

Comparison of efficacy of ultrasound- guided erector spinae plane block versus local wound infiltration for post-operative analgesia in patients undergoing video-assisted thoracoscopic surgery: a double blind randomised controlled trial

Monika Yadav1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
The time to request the first post-operative rescue analgesic dose

研究概览

简要总结

This study is a randomized, double blind, parallel group, single-centre trial comparing the efficacy of ultrasound-guided erector spinae plane block versus local wound infiltration for post-operative analgesia in patients undergoing video-assisted thoracoscopic surgery in 110 patients in a tertiary care centre in India. The primary outcome measure will be to determine the time to request the first post-operative rescue analgesic dose. The secondary outcomes will be total post-operative rescue analgesic requirement, comparison of quality of recovery, incidence of nausea and vomiting in the first 24 hours post-operatively and numerical rating score at rest and during coughing, comparison of sedation scores at 6, 12, and 24 hours post-operatively

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • Informed and written consent ASA physical status 1 and 2 Elective video-assisted thoracoscopic surgery.

排除标准

  • Patient refusal Infection at the site Chronic pain patients or patients with analgesic dependence INR more than 1.5 Difficulty in understanding or non-compliance with the quality of recovery questionnaire.

结局指标

主要结局

The time to request the first post-operative rescue analgesic dose

时间窗: The time point at which the patient requests the first post-operative rescue analgesic dose in first 24 hours.

次要结局

  • Total post-operative rescue analgesic requirement(24 Hours post-operatively)
  • Numerical rating score at rest and during coughing(6 ,12 and 24 Hours post-operatively)
  • Comparison of quality of recovery(24 Hours post-operatively)
  • Comparison of sedation scores(6,12, and 24 Hours post-operatively)
  • Incidence of nausea and vomitting(Post-operative period for 24 Hours)

研究者

发起方
Monika Yadav
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

Monika Yadav

Medanta -The Medicity

研究点 (1)

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