跳至主要内容
临床试验/CTRI/2024/01/061177
CTRI/2024/01/061177尚未招募不适用

A Randomized Comparison Between ultrasound guided Vs ultrasound with PNS guided Sciatico-Femoral Nerve Block for Lower Limb Below Knee Surgeries

Unmekha Pardhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
The aim of the study is to compare quality of anaesthesia in both the

研究概览

简要总结

Over the past ten years, ultrasound guiding has grown in popularity and

has made it possible to do numerous peripheral nerve blocks that were previously impractical to carry out

using conventional methods. Many different forms of peripheral nerve blocks have been performed on

both adults and children in recent years using ultrasound technology [1–9]. Direct visualization of nerve

structures, real-time needle guidance to the target, and tracking of local anesthetic diffusion are all made

possible by ultrasound imaging. [10] According to certain reviews and meta-analyses, ultrasound-guided

peripheral nerve blocks may have a number of advantages, such as a higher success rate, a quicker

commencement of blocks, and perhaps better quality sensory blocks [11–16]. Sciatic nerve blocks are

frequently used in clinical practice to provide anesthesia and analgesia during lower limb surgery. Nerve

stimulation guidance is a traditional technique for sciatic nerve block [17,18] popular regional anesthesia

(RA) procedure for delivering anaesthetic or analgesia for below knee surgery is the sciatic nerve either

by itself or in conjunction with a femoral or saphenous nerve block, it is employed. We proposed that

using ultrasonography combined with PNS guidance to block both sciatic nerve branches would achieve

good quality of anaesthesia and will shorten the duration of the sciaticofemoral nerve block. The goal of

the current study was to compare the use of combined ultrasound and pr(PNS) guidance with the

ultrasound guidance alone.

  1. MATERIALS AND METHODS: - 80 consenting patients fulfilling the inclusion criteria will

be considered for study. Workup will be done for all patients which included a detailed History, General

physical and systemic examination and all basic investigations will be done. Patients undergoing lower

limb surgery as per the routine procedure and requirement will undergo sciatico femoral block with either

ultrasonography or ultrasonography and peripheral nerve stimulator. GROUP U: - Will be the one who

would have received Ultrasonography guided sciatico-femoral nerve block with drug Inj. Lignocaine2%

with Adrenaline + Inj. Bupivacaine 0.5% + Inj. Dexamethasone 8 mg (total volume 40 cc) and GROUP

UP: - Will be given combined Ultrasonography and PNS guided sciatico-femoral nerve block with drug

Inj. Lignocaine2% with Adrenaline + Inj. Bupivacaine 0.5% + Inj.Dexamethasone 8 mg (total volume 40

cc). Hemodynamic monitoring will be done. All patients will be meticulously monitored intraoperatively

for -A) Haemodynamic parameters {HR ,SBP,DBP,MAP,SPO2}B) Sensory Blockage will be assessed

by pin prick test using 3-point scale C) Motor grade using modified bromage scale.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • American Society of Anaesthesiologists physical status I-II
  • Patients schedule for below knee surgery
  • Ultrasound visibility score equal or greater than 10.

排除标准

  • ASA III and IV
  • Pregnant PAtients
  • Patients with coagulation disorders.

结局指标

主要结局

The aim of the study is to compare quality of anaesthesia in both the

时间窗: Baseline, 15 min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min.

groups. Primary objective is to compare the onset time of sensory and motor blockade of

时间窗: Baseline, 15 min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min.

Sciatico-femoral block by USG alone vs USG with PNS guidance.

时间窗: Baseline, 15 min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min.

次要结局

  • 2) To compare Performance time of block (Performance time of block is the preparing time and procedure time. Preparing time defined as the time from the beginning of the sterile preparation right before the first needle contact with the skin. Procedure time is time between the insertion of the needle and the end of local anaesthetic injection)(3) To compare duration of post op analgesia. (time to first rescue analgesic))

研究者

发起方
Unmekha Pardhi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Unmekha Pardhi

BJGMC and SGH, Pune

研究点 (1)

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