跳至主要内容
临床试验/CTRI/2022/08/044541
CTRI/2022/08/044541招募中不适用

Comparison between Efficacy of Analgesia Produced by Intravenous Analgesics and Ultrasound Guided Peripheral Nerve Block among Isolated Single Extremity Trauma patients in Emergency Department; An Exploratory Randomized Controlled Study

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Primary outcome in both groups will be measured using NRS score. Calculation of NRS score will be started 30min after the intervention (nerve block/IV analgesics) and then will be continued every hour till patient stay in ED

研究概览

简要总结

Pain is the most common complaint in a trauma emergency department. In a busy trauma ED pain management is often neglected i/v/o more life threatening injuries; however, untreated/poorly treated pain can result in complications like PTSD later on, at the same time stress response to significant pain might increase patient’s morbidity. The use of peripheral nerve block as a potent mode of anesthesia and analgesia is well approved and quite frequent among anesthetists inside OT. Pain management in trauma ED has been conventionally done with IV analgesics (Paracetamol, opioids, NSAIDs). Often, some of these drugs are contraindicated in a polytrauma patient (eg:  opioids should be used cautiously in head injury patients). The use of peripheral nerve block for analgesia in trauma ED is an area yet to be adequately explored. Through this study, we are trying to establish a new pain management protocol for acute trauma victims for better patient satisfaction.

Acute trauma patients coming to trauma emergency will be first managed as per ATLS protocol and then will be evaluated based one of inclusion and exclusion criteria. Randomization will be then done and after informed consent patients will be treated with conventional IV analgesics(Inj Paracetamol 1gm IV 6th hourly with Inj Tramadol 15mg/kg 8th hourly)/peripheral nerve block (Inj Bupivacaine 0.25% @ 0.3ml/kg). The efficacy of analgesia will be compared using NRS (Numeric Rating Score) hourly along with other parameters like vitals, adverse effects of used medications, patient satisfaction etc.

There are some studies proving the efficacy of peripheral nerve block over IV analgesics in trauma emergency, however, as per the author’s knowledge, no Indian study has been done in this regard so far. So this study will help in developa ing new pain management protocol for better patient management as well as satisfaction.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Patients above 18 years to 70years of age will be included.

排除标准

  • •patients with polytrauma patients with hemodynamic instability patients with associated GCS<15 patients not willing/not able to give consent patients with a known allergic reactions to local anesthetics.

结局指标

主要结局

Primary outcome in both groups will be measured using NRS score. Calculation of NRS score will be started 30min after the intervention (nerve block/IV analgesics) and then will be continued every hour till patient stay in ED

时间窗: Primary outcome in both groups will be measured using NRS score. Calculation of NRS score will be started 30min after the intervention (nerve block/IV analgesics) and then will be continued every hour till patient stay in ED

次要结局

  • Patient satisfaction (will be calculated using 5 point Likert scale) at the end of ED stay(Length of hospital stay)

研究者

申办方类型
Government medical college

研究点 (1)

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