跳至主要内容
临床试验/CTRI/2021/04/032715
CTRI/2021/04/032715已完成不适用

Analgesic Efficacy of USG Guided Pericapsular Nerve Group Block Versus Intravenous Nalbuphine Hydrochloride In Patients of Intracapsular And Pericapsular Bony Hip Injuries: A Randomised Controlled Trial.

Aiims Bhubaneswar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Numerical rating scale (NRS Scale)

研究概览

简要总结

Hip fractures are a harrowing and dangerous orthopaedic emergency that commonly presents to the emergency department.

These painful hip fractures are often managed with opioid analgesics like IV morphine or nalbuphine.

But most of them are undermedicated in an overcrowded ED setup with limited resources to monitor as there are a lot of undesirable adverse effects like respiratory depression, bradycardia, hypotension and delirium, which gets aggravated especially if used in older patients.

An equally effective alternative to IV opioids can be PENG block which is a peripheral nerve block.

The PENG block was derived from the femoral nerve’s articular branches, obturator nerve, and accessory obturator nerve that provide sensory innervation to the anterior capsule of the hip joint. It was developed as a safe and potentially more effective alternative to femoral nerve block (FNB) and fascia iliaca block (FIB) for hip injuries.

As the injection targets the terminal branches of sensory nerves, it has only a motor-sparing effect facilitating early mobilization.

There have only been two case series about PENG block available in the literature, but no RCT has yet been done.

This RCT can set a milestone in managing inadequate analgesia in hip fractures in ED set up and better patient compliance.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • patients presenting with traumatic injuries to the hip and radiologically confirmed to be a 1.fracture of surgical neck of the femur 2.intertrochanteric fracture of femur 3.sub capital fracture of the femur 4.fracture of acetabulum 5.fracture of the pubic ramus 6.patients with NRS pain score≥5.

排除标准

  • 1.Infection over the skin at the site of block 2.The shaft of femur fracture 3.Allergic to local anesthetic 4.Coagulopathy 5.Pregnancy 6.Altered mental status 7.Hip Dislocation 8.patient not giving consent 9.patients who received analgesic before the block 10.Associated with other bony injuries(except the inclusion criteria).

结局指标

主要结局

Numerical rating scale (NRS Scale)

时间窗: Numerical rating scale (NRS Scale)baseline,30 mins,1 hour,2 hour,4 hour,6 hour

次要结局

  • To determine the need for rescue analgesia in both arms.(6 hours,12 hours)
  • To study the adverse effect in both the arms.(30 mins,2 hours,4 hours, 6hours, 12 hours)

研究者

申办方类型
Government medical college

研究点 (1)

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