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临床试验/CTRI/2025/09/095251
CTRI/2025/09/095251尚未招募4 期

Comparative study of Ropivacaine epidural infusion versus IV Dexmedetomidine infusion for postoperative pain management and hemodynamic stability in open Urological surgeries

Supreet kaur1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月6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
70
试验地点
1
主要终点
• Postoperative pain scores using VAS .

研究概览

简要总结

Effective postoperative pain management is essential for early recovery, reduced morbidity and patient satisfaction. Ropivacaine a long acting amide local anesthetic , administered via epidural infusion ,provides effective segmental analgesia, reduced systemic

opioid requirement. on the other hand , Dexmedetomidine , a highly selective alpha 2- adrenergic agonist ,when given intravenously, offers analgesia and sedation thereby maintaining hemodynamic stability with opioid sparing effects.

This comparative study aims to evaluate the efficacy and safety of continuous epidural infusion of Ropivacaine verses intravenous infusion of Dexmedetomidine in patients undergoing open urological surgeries. The primary objective includes assessment of post

operative pain scores and hemodynamic parameters, while secondary outcomes will focus on sedation levels and requirement of rescue analgesic.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status 1-3 2)Scheduled for elective open urological surgeries(nephrectomy,pyeloplasty,radical nephrectomy,radical cystectomy) 3)Willing to give informed consent.

排除标准

  • Patients with known allergy to local anesthetics or dexmedetomidine
  • Contraindications to epidural catheter placement (coagulopathy, infection at insertion site, severe spinal deformity)
  • Severe cardiovascular disease (uncontrolled hypertension, heart block, cardiac failure)
  • Severe hepatic or renal impairment
  • History of chronic pain requiring regular analgesics
  • Psychological disorders that may affect pain assessment
  • Pregnancy or lactation9
  • Unable to comprehend visual analog scale (VAS).

结局指标

主要结局

• Postoperative pain scores using VAS .

时间窗: baseline | 2hours | 4hours | 6hours | 12hours | 24hours | 36hours | 48hours

次要结局

  • 1. Time to first rescue analgesic requirement.(2. Total consumption of rescue analgesics in the first 48 hours postoperatively.)

研究者

发起方
Supreet kaur
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Supreet kaur

Adesh institute of medical science and research.

研究点 (1)

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