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临床试验/CTRI/2024/06/068519
CTRI/2024/06/068519尚未招募不适用

A Randomized comparative study of ultrasound guided(USG) pericapsular nerve group block (PENG) using 0.25% Bupivaicaine with or without magnesium sulphate for positional comfort during neuraxial block in hip fracture patients

Department of Anaesthesiology VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年6月17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
64
试验地点
1
主要终点
Assessment of reduction in PAIN using NRS(Numerical rating scale) scores following administration of PENG block IN BOTH GROUPS

研究概览

简要总结

A Prospective Double Blinded Randomized Comparative study of Ultrasound guided (USG) Pericapsular Nerve Group Block (PENG) using ) 0.25% Bupivaicaine with or without magnesium sulphate for positional comfort during neuraxial block in Hip fracture patients.

PENG block is a newer technique using USG guidance to block femoral nerve and obturator nerve and sparing quadriceps femoris muscle. The aim of study is to compare the efficacy of PENG block with or without magnesium sulphate for  positional comfort during neuraxial block in patients of age of 18- 70 yrs scheduled for emergency / elective hip surgeries .

Thorough preoperative evaluation and neccessary investigations and informed consent of patients / relatives is taken. In preoperative room, all patients are randomly allotted to one of 2 groups, group M and group N by computer generated randomization via Research Randomizer Software ( www.randomizer.org).The allocation concealment is ensured using sequentially numbered opaque sealed envelope (SNOSE) technique.The study solutions prepared by one anaesthesiologist who will not be involved in further study.

In preoperative area , all patients will be secured with 18 G IV cannula , started ringer lactate (RL) IV fluids  and monitored for NIBP, ECG and SPO2 .  Pain during rest and pain on 30 degree passive limb elevation will be assessed by NRS ( Numerical Rating Scale).Routine preparation of anaesthesia machine and drugs will be done.

Takaing all precautions ,under aseptic conditions , a low frequency curvilinear USG probe ( 2-5 MHz) will be placed over line joining anterior superior iliac spine(ASIS)  and pubic tubercle , keeping lateral margin at ASIS and adjusted probe to get sono -anatomical view of PENG block. The needle entry point on skin is selected in such a manner that perpendicular needle entry will guide needle near target point (ilio-pubic eminence), 21 G peripheral nerve stimulator (PNS) needle is inserted to reach bony rim near ilio-pubic eminence avoiding injury to femoral nerve. In Group M 18 ml 0.25% Bupivaicaine with 2 ml 10% magnesium sulphate and in group N 18 ml of 0.25 % Bupivaicaine with 2ml of normal saline slowly injected with repeated aspirations to avoid intravascular injections.

Outcomes to be assessed after PENG BLOCK in both groups:

  • After 30 minutes pain will be reassesed at rest and 30 degree passive limb elevation by using NRS pain intensity score .
  • The comfort during sitting for spinal anaesthesia will also be assessed by EOSP(EASE OF SPINAL ANAESTHESIA) score.
  • Time taken for first rescue analgesia after PENG BLOCK.
  • Total rescue analgesia required in the first 24 hours.

The following data will be collected : Demographic parameters of the patients such as age, height , weight, body mass index , vital parameters like heart rate , respiratory rate, ECG, oxygen saturation and MAP mean arterial pressure before and after delivering analgesia . Any adverse events such as bleeding , needle kinking will also be noted. Fluid management is done as per standard fluid resuscitation guidelines. all data ( related to variables of study ) assessed , will be entered in MS EXCEL sheet , cleaned and analysed. Related categorical and numerical variables will be subjected to suitable statistical tests. The numerical variables will be assessed for uniformity of distribution , before assessing for parametric and non parametric tests.

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

  • ASA 1 ,2 & 3 Patient with normal cardiopulmonary function.

排除标准

  • refusal by patients deranged coagulation profile patient with mental, neurological , severe cardiovascular disease.
  • punture site infection allergy to local anesthetics neuromuscular diseases history of epilepsy and alchoholism.

结局指标

主要结局

Assessment of reduction in PAIN using NRS(Numerical rating scale) scores following administration of PENG block IN BOTH GROUPS

时间窗: COMPARING NRS PAIN SCORING 30 MINUTES AFTER PENG BLOCK IN BOTH GROUPS

次要结局

  • QUALITY OF PATIENT POSITIONING BY EOSP SCORE IN BOTH GROUPS(30 MINS AFTER PENG BLOCK COMPARING EOSP SCORE IN BOTH GROUPS)
  • TIME TAKEN FOR FIRST RESCUE ANALGESIA AFTER PENG BLOCK IN BOTH GROUPS(WITHIN 24 HRS OF PENG BLOCK)
  • TOTAL RESCUE ANALGESIA USED IN BOTH GROUPS(TOTAL RESCUE ANALGESIA USED IN FIRST 24 HRS AFTER PENG BLOCK IN BOTH GROUPS)

研究者

发起方
Department of Anaesthesiology VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

ARSHITHA SHRI U R

Vijayanagar Institute Of Medical Sciences , Ballari

研究点 (1)

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