跳至主要内容
临床试验/CTRI/2024/10/074902
CTRI/2024/10/074902招募中不适用

"Analgesic Efficacy of Single-shot Versus Continuous Supra-inguinal Fascia Iliaca Compartment Block (S-FICB) using Ropivacaine for Elderly Proximal Femur Fracture patient ni the EmergencyDepartment: ARandomizedControledStudy."

AIIMSBHUBANESWAR1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年10月19日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.

研究概览

简要总结

Hip and proximal femur fractures, comprising 20% of all fractures in the elderly, are rising due to the aging population.Intense pain associated with proximal femur fractures can be worsened by position changes during examination, transport, or treatment. This augmented pain response can trigger adverse cardiovascular and cerebrovascular complications.

The Fascia Iliac Block is increasingly used to reduce hip fracture pain**.** In recent years, USG -a guided supra-inguinal FICB approach has emerged as a novel method for performing FICB. It is safely performed with minimal risk as the needle trajectory does not cross major vessels, and the intended site of drug deposition is relatively superficial. The Supra inguinal approach, a recent advance over the conventional approach, ensures a more consistent spread of Local anesthetics (LA). It provides (80%) sensory blockade of the thigh than the previous method(30%).

The single-shot S-FICB provides analgesia for approximately eight hours**,** and few other studies show that its effect starts wearing off around 24 hrs. We wanted to prolong the analgesia period by inserting a catheter and providing continuous LA infusion through the elastomeric infusion system without electricity. It gives a consistent supply of drugs and does not require detachment during transportation.

Hence this study is designed to assess and compare the analgesic efficacy of USG-guided single-shot Suprainguinal Fascia Iliaca Compartment Block (S-FICB) to Continuous S-FICB  using a continuous catheter and infusing through an elastomeric infusion pump in elderly patients with proximal femur fracture presenting to to the Emergency Department (ED).

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
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex aged 60 years to 90 years with (ASA) physical status I-IV presenting to ED with acute proximal femur fracture.

排除标准

  • Exclusion criteria: 1) other organ severe trauma with unstable hemodynamics at the presentation.
  • coagulation disorder 3) Taking Analgesics for a longer duration or with opioid addiction 4) History of allergy to local anesthetics 6) Having cognitive impairment.
  • Puncture site infection 8) Abnormal neurological status of the lower limbs 9) voluntary withdrawal by patients.

结局指标

主要结局

We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.

时间窗: We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.

次要结局

  • MAP, HR, SPO2 at the time of evaluation of VAS(The amount of opioids as a rescue analgesia)

研究者

发起方
AIIMSBHUBANESWAR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Subhasree Das

Department Of Trauma and Emergency,AIIMS Bhubaneswar

研究点 (1)

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