跳至主要内容
临床试验/CTRI/2020/12/029997
CTRI/2020/12/029997尚未招募不适用

Efficacy of erector spinae plane block versus peritubal analgesic infiltration for post operative pain following percutaneous nephrolithotomy: A prospective randomized trial.

Muljibhai Patel Urological Hospital Nadiad1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To compare the analgesia efficacy by visual analogue scale and need of rescue analgesia

研究概览

简要总结

Percutaneous nephrolithotomy (PCNL) is commonly performed to treat the kidney stone. There are several effort has been done to minimise the postoperative pain such as multimodal analgesic regimens.[1-3]  Ultrasound-guided erector spinae plane block (ESPB) is a novel interfascial paraspinal plane regional anesthesia technique, which was first used by Forero et al for the treatment of severe chronic thoracic neuropathic pain.[4]. Although the majority of ESPBs described were in the thoracic region and few studies available for the lumbar region for postoperative analgesia.[5]  The studies reported that it was an effective technique for postoperative analgesia in patients having ventral hernia repair [6], breast surgery [7], laparoscopic cholecystectomy procedures [8] and PCNL[9, 10]. The peritubal infiltration along the renal capsule, subcutaneous tissue, skin and nephrostomy tube is carried out after PCNL is another effective method for postoperative analgesia.[11] There was no reported study for comparison of ESPB versus peritubal infiltration for postoperative analgesia for PCNL. The aim of this randomized, controlled, single-blinded study was to compare the analgesic efficacy of ultrasound-guided ESPB versus peritubal infiltration versus no intervention.

研究设计

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

  • 1.Patients with American Society of Anesthesiologists (ASA) physical status classes I or II, 2.Aged 18–65 years 3.Scheduled for all unilateral PCNL, Mini PCNL and Tubeless PCNL under General anesthesia (GA).

排除标准

  • 1.Psychological disorders, 2.Morbid obesity ( BMI>35), hepatic or renal dysfunction, 3.Coagulation disorders, 4.Sepsis, history of chronic analgesic use 5.History of allergy to local anesthetic agents 6.Restage PCNL.

结局指标

主要结局

To compare the analgesia efficacy by visual analogue scale and need of rescue analgesia

时间窗: 24 hours after procedure postoperatively

次要结局

  • To compare the hemodynamic stability, duration of analgesia and total dosage of analgesia consumption(24 hours after procedure postoperatively)

研究者

发起方
Muljibhai Patel Urological Hospital Nadiad
申办方类型
Research institution and hospital

研究点 (1)

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