跳至主要内容
临床试验/CTRI/2024/05/067378
CTRI/2024/05/067378尚未招募4 期

A COMPARATIVE STUDY OF ULTRASOUND GUIDED PERICAPSULAR NERVE GROUP BLOCK (PENG) VERSES FEMORAL NERVE BLOCK (FNB) FOR POSITIONING DURING SPINAL ANESTHESIA IN PROXIMAL FEMUR FRACTURES

BOKARO GENERAL HOSPITAL1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年5月26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
54
试验地点
1
主要终点
Visual assessment score at rest and dynamic

研究概览

简要总结

Severe pain associated with proximal femur fracture makes spinal anaesthesia in sitting position difficult. Regional blocks such as femoral nerve block (FNB) and fascia iliaca compartment block (FICB) provide good analgesia for positioning. FNB is easy to perform and safe. It has been used for years to provide analgesia for sitting position for performing central neuraxial blockage after hip fractures. However, it can lead to motor weakness. Pericapsular nerve group block (PENG) blocks the articular fibres of femoral nerve, obturator nerve and accessory obturator nerve.supplying anterior hip capsule. So, we aim to compare the analgesic effect of USG guided PENG block and FNB for positional pain during spinal anaesthesia in proximal femur fractures.

The minimum sample size required for our study is 54.

Randomisation of the sample will be done by computer generated using random number generator to create list of random numbers.

GROUP A to get USG guided PENG block 30 mins before spinal anaesthesia.

GROUP B to get USG guided FNB 30 mins before spinal anaesthesia.

In preoperative room, pain score at rest (VAS-R) and at 15-degree passive limb elevation in supine position will be noted.

Under all aseptic and antiseptic precautions, PENG block and FNB block will be given using 20 mL of 0.25% bupivacaine after negative aspiration via 22G block needle.

VAS will be assessed at rest (VAS -R and at 15-degree limb elevation (VAS-D) every 10 mins for 30 mins. At 30 mins, patients will be shifted to the operating room.

Patient is given a sitting position for spinal anaesthesia and comfort is assessed by ease of spinal position score (EOSP). If VAS is >4, it is considered a block failure.

The best angle obtained by the patient during sitting position is also recorded.

Post operative pain scoreis assessed by VAS at 2, 4, 6, 8, 12, 24 hrs.

Quadriceps muscle weakness will be assessed by Oxford muscle strength scale at 6 hrs.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • 1.ASA grade 1 & 2 patients.
  • 2.Elective orthopedic surgeries under spinal anesthesia.
  • 3.Patient willing to give written informed consent.

排除标准

  • 1.Patient refusal 2.ASA grade 3 & 4 3.Local site infection 4.Coagulopathies 5.Polytrauma 6.Allergy to local anesthetics 7.Patient with old fractures (more than 7 days) 8.Difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness.

结局指标

主要结局

Visual assessment score at rest and dynamic

时间窗: 10 mins after block | 20 mins after block | 30 mins after block

次要结局

  • Best angle obtained by the patient during sitting position during spinal anesthesia(Ease of spinal position score)

研究者

发起方
BOKARO GENERAL HOSPITAL
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR VIVEK KUMAR

Bokaro General Hospital Bokaro

研究点 (1)

Loading locations...

相似试验