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临床试验/CTRI/2024/10/075374
CTRI/2024/10/075374尚未招募4 期

Comparison of efficacy and safety of different doses of dexmedetomidine combined with ropivacaine for caudal block in lumbosacral surgeries a prospective randomized controlled study

未提供1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
38
试验地点
1
主要终点
1. To evaluate and compare the analgesic effect of caudal epidural injection of different doses of dexmedetomidine with ropivacaine postoperatively

研究概览

简要总结

The rise in spine pathology correlates with increased mechanized work and sedentary lifestyles, leading to a higher demand for spinal surgeries. Postoperative pain from lumbosacral surgeries is often due to irritation of nociceptors and mechanoreceptors, and it can persist long after surgery due to inflammatory processes. This pain can delay mobilization, increasing the risk of complications such as pneumonia and deep vein thrombosis. Caudal analgesia offers a reliable method for managing intraoperative and postoperative pain. Preemptive analgesia can also reduce sensitization from noxious stimuli. Ropivacaine, a local anesthetic, provides effective pain relief while preserving motor function. The current trend favors multimodal pain control, incorporating adjuvants like dexmedetomidine, which enhances local anesthetic efficacy. Despite the benefits, there are limited randomized studies on preemptive caudal analgesia in lumbosacral surgeries. This study aims to compare the analgesic effects and side effects of different doses of dexmedetomidine combined with ropivacaine when given as single shot caudal  epidural block preemptively.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patient scheduled for lumbosacral spine surgery Patient aged between 18years to 65years Patient with ASA grades 1 and 2 with both the sexes.

排除标准

  • Patient not willing to consent Patients with coexisting diseases like uncontrolled hypertension, diabetes, asthma, history of MI, CAD, etc Patients with preoperative opioid consumption Patients who underwent a previous lumbar spine surgery Patients with contraindications to regional anesthesia like the history of coagulopathies, preexisting neurologic deficit, active infection at the site of injection,etc Patients with hypersensitive to ropivacaine and dexmedetomidine Any lumbosacral anamoly Surgery exceeding more than 5hours.

结局指标

主要结局

1. To evaluate and compare the analgesic effect of caudal epidural injection of different doses of dexmedetomidine with ropivacaine postoperatively

时间窗: Intraoperative and postoperative period

次要结局

  • 1.assess the hemodynamic effects of dexmedetomidine intraoperatively(2. To see the incidence of adverse effects between the two doses)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Ananya Rao

AIIMS RAIPUR

研究点 (1)

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