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临床试验/CTRI/2024/03/064389
CTRI/2024/03/064389尚未招募2/3 期

Effects of erector spinae block on the postoperative quality of recovery after Gender Reassignment chest surgeries: a prospective randomized double-blinded study

Krishna prasad T1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月28日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
first onset of pain, rescue analgesia

研究概览

简要总结

Regional anesthesia techniques in addition to general anesthesia for postoperative pain have been in practice. Those techniques are performed under ultrasound guidance as part of multimodal analgesia in both intraoperative and postoperative periods. Among the supportive techniques, Erector spinae plane block (ESPB) was first defined for thoracic neuropathic pain treatment in 2016 and was found to provide sufficient postoperative analgesia in thoracic, breast, bariatric, and upper abdominal surgeries concerning the anatomical level applied 1. Although the exact mechanism of ESPB is unknown, it has gained popularity as a result of the growing number of randomized trials that have demonstrated its effectiveness**.**

  Statistically meaningful increases in postoperative analgesia and reductions in opioid intake, however, can only be clinically significant if they promote a better recovery quality. Whether a relationship exists between ESPB and postoperative recovery quality is still unknown, especially in bilateral breast or chest surgeries.

               Postoperative recovery after surgery and anesthesia is a complex and multidimensional process 2. Inadequate recovery quality negatively influences both the patient and the medical team. Although a delayed return to normal activities may produce dissatisfaction with the medical service received prolonged recovery or delayed discharge also significantly impacts the medical team’s resource utilization 3.

 Therefore, we hypothesized that ESPB could also provide a better quality of recovery in patients who underwent Reassignment Chest surgery, as it allows effective post-operative pain control.

 The primary outcome of this study was to evaluate the effectiveness of ultrasound-guided ESPB on postoperative quality of recovery after surgery using the 40-item quality of recovery  (QoR-40) questionnaire. Evaluation of the effects of ESPB on postoperative pain, opioid con- consumption, and nausea and vomiting was determined as the further outcome of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Both sexes and for transfeminine surgeries.

排除标准

  • not willing for injections.

结局指标

主要结局

first onset of pain, rescue analgesia

时间窗: pain assessed at time intervals like 2, 4, 6,8,12 and 24 hours after the block

次要结局

  • complications for the procedure(at intervals in 4, 8, 12 & 24 hours noted. after rescue analgesia)

研究者

发起方
Krishna prasad T
申办方类型
Other [self funding]
责任方
Principal Investigator
主要研究者

Dr Krishna Prasad T

Shri Sathya Sai Medical College

研究点 (1)

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