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临床试验/CTRI/2025/11/097158
CTRI/2025/11/097158尚未招募不适用

A comparative study of efficacy of Ropivacaine 0.25 percent versus Ropivacaine 0.375 percent with dexmedetomidine as adjuvant in ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy

Sapthagiri institute of medical sciences and research centre Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月21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
70
试验地点
1
主要终点
To compare the efficacy of 0.25% versus 0.375% ropivacaine with a fixed dose of dexmedetomidine as adjuvant in ultrasound-guided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy

研究概览

简要总结

Laparoscopic abdominal surgery offers numerous advantages including improved early postoperative ambulation and reduced surgical trauma leading to faster recovery and fewer complications compared with open surgery However despite these benefits patients frequently experience significant postoperative pain especially in the early recovery period which can hinder mobilization increase opioid consumption and contribute to chronic pain development Effective postoperative analgesia is therefore essential for patient comfort accelerated rehabilitation and minimization of opioidrelated adverse effects

Multimodal analgesia strategies incorporating nonopioid medications and regional nerve blocks have become standard for managing pain after laparoscopic procedures The ultrasoundguided erector spinae plane ESP block first described by Forero et al in 2016 is an interfascial plane block that provides both visceral and somatic analgesia by diffusion of local anesthetic into the paravertebral and epidural spaces Its simplicity under ultrasound guidance and favorable safety profile have led to rapid adoption in thoracic and abdominal surgeries Ropivacainea longacting amide local anestheticis preferred in regional techniques due to its lower cardiotoxicity and improved motorsensory separation The concentration of ropivacaine influences block quality duration and sideeffect profile however direct comparisons of different concentrations in ESP blocks for laparoscopic surgery remain scarce Dexmedetomidine a highly selective  adrenergic agonist is increasingly used as an adjuvant in regional anesthesia When added to local anesthetic low dose dexmedetomidine prolongs sensory block duration enhances analgesia and reduces    opioid  requirements without significant hemodynamic instability The aim of this study is to compare the efficacy of 025 versus 0375 ropivacaine each with a fixed dose of dexmedetomidine as adjuvant in ultrasoundguided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

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 Age 18-65 years, both sexes 2 ASA physical status 1 and 2 3 Scheduled for elective laparoscopic cholecystectomy 4 Patients willing to give informed consent.

排除标准

  • 未提供

结局指标

主要结局

To compare the efficacy of 0.25% versus 0.375% ropivacaine with a fixed dose of dexmedetomidine as adjuvant in ultrasound-guided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy

时间窗: Postoperatively, VAS scores will be recorded at 1, 5min, 10min, 30min , 1hr , 2hr , 4hrs , 8hrs ,12hrs and 24 hours, and patients will be monitored for nausea, vomiting, sedation, respiratory depression, and shoulder pain

次要结局

未报告次要终点

研究者

发起方
Sapthagiri institute of medical sciences and research centre Department of Anaesthesia
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Jaswanth M D

Sapthagiri Institute of Medical Sciences and Research Centre

研究点 (1)

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