跳至主要内容
临床试验/CTRI/2024/11/077202
CTRI/2024/11/077202尚未招募4 期

A Randomized Comparative Study to Assess the Effectiveness of USG Guided Mandibular Nerve Block Using 0.5 percentage Ropivacaine for Post-Operative Pain Reduction in Cases of Fracture Mandible Posted for Open Reduction and Internal Fixation in Department of Anaesthesia, SMS Medical College, Jaipur.

SMS Medical College Jaipur1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年12月1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
72
试验地点
1
主要终点
1.Mean NRS score at different time interval in post operative period 24 hours after surgery

研究概览

简要总结

The surgery for mandibular fracture fixation can cause severe pain in the immediate postoperative period. Most of these patients are managed with intravenous opioids. Mandibular nerve block provides good perioperative analgesia for mandibular surgeries. They can be used as part of multimodal analgesia to reduce the consumption of opioids in the postoperative period. The purpose of pre-emptive analgesia is not only to provide better postoperative analgesia but also to reduce the consumption of opioids and anesthetic agents intraoperatively.

•Our study aims to compare the consumption of opioid for 24 hours in both groups postoperatively in cases  mandible fracture surgeries undergoing ORIF by using  0.5% ropivacaine  and to compare the time for a request for rescue analgesic, intraoperative hemodynamic parameters and Numerical Rating Scale (NRS) scores for 0,3,6,9,12 and 24 hour postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients posted for ORIF of fracture of mandible 2.Patients consenting to participate.
  • 3.Adult patients aged 18 years -60 years.
  • 4.Patients belonging to American Society of Anaesthesiologists (ASA) grade I and II.

排除标准

  • 1.Patients part of other study 2.Non co-operative patients 3.H/O allergic reactions to local anesthetics 4.coagulation disorders.
  • 5.Local infection at the proposed site of puncture for mandibular nerve block.
  • 6.Fracture of symphysis 7.pregnant patients.

结局指标

主要结局

1.Mean NRS score at different time interval in post operative period 24 hours after surgery

时间窗: at baseline ,3rd hour ,6rd hour ,9th hour ,12th hour,24 th hourly in post operative period

2.Mean time for first rescue analgesia.

时间窗: at baseline ,3rd hour ,6rd hour ,9th hour ,12th hour,24 th hourly in post operative period

3.Total consumption of opioids during first 24 hours

时间窗: at baseline ,3rd hour ,6rd hour ,9th hour ,12th hour,24 th hourly in post operative period

次要结局

  • Hemodynamic variables (HR, SBP, DBP, MAP, SpO2) in first 24 hours(Proportion of cases with complications in first 24 hours .)

研究者

发起方
SMS Medical College Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR VANDANA MANGAL

sawai man singh medical college jaipur

研究点 (1)

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