跳至主要内容
临床试验/CTRI/2025/05/086347
CTRI/2025/05/086347尚未招募4 期

To compare efficacy of ropivacaine along versus ropivacaine with magnesium sulphate for post operative analgesia in peripheral nerve stimulator guided supraclavicular plexus block in upper limb surgeries

Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月17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
50
试验地点
1
主要终点
Duration of postoperative analgesia, measured as the time from administration of the supraclavicular plexus block to the first request for rescue analgesia.

研究概览

简要总结

This study aims to compare the efficacy of Ropivacaine alone versus Ropivacaine combined with Magnesium Sulphate for postoperative analgesia in patients undergoing upper limb surgeries under a peripheral nerve stimulator-guided supraclavicular plexus block. The primary outcome is the duration of postoperative analgesia, while secondary outcomes include pain intensity, total rescue analgesic consumption, and the incidence of adverse effects. The study will recruit adult patients aged 18–65 years of both sexes, adhering to strict inclusion and exclusion criteria to ensure safety and reliability of results.

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

  • Patients undergoing upper limb surgeries requiring supraclavicular plexus block.
  • American Society of Anesthesiologists (ASA) Physical Status I and II.
  • Willing to provide written informed consent.
  • Body mass index (BMI) within the range of 18–30 kg/m².

排除标准

  • Patients with known hypersensitivity to Ropivacaine, Magnesium Sulphate, or local anesthetics.
  • History of coagulopathy or bleeding disorders.
  • Presence of infection at the injection site.
  • Patients with severe systemic diseases (e.g., ASA Physical Status III and above).
  • Neurological or psychiatric disorders affecting pain perception.
  • Pregnant or lactating women.
  • Patients on chronic opioid therapy or magnesium supplements.
  • Refusal to consent to participate in the study.

结局指标

主要结局

Duration of postoperative analgesia, measured as the time from administration of the supraclavicular plexus block to the first request for rescue analgesia.

时间窗: 2 years

次要结局

  • Pain intensity, assessed using the Visual Analog Scale (VAS) at 2, 4, 6, 12, and 24 hours postoperatively.(Evaluated at 2, 4, 6, 12, and 24 hours postoperatively.)

研究者

发起方
Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sikha Subhadarshini

Jawaharlal Nehru medical college

研究点 (1)

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