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临床试验/CTRI/2024/11/077432
CTRI/2024/11/077432尚未招募2 期

Buprenorphine vs Clonidine as adjuvant for ultrasound guided popliteal sciatic nerve block in lower limb surgeries,A double blinded randomised study

Chettinad hospital and research institute1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
To compare the duration of analgesia

研究概览

简要总结

INTRODUCTION

  • The aim of the study was to compare the effectiveness of ultrasound-guided popliteal nerve block with two different additives with 2% xylocaine adrenaline in below knee surgeries,The popliteal nerve block is a block of the sciatic nerve in the popliteal fossa with the patient in the prone position,The block is ideal for surgeries of the lower leg, particularly the foot and ankle.

  • By using ultrasound,the local anesthetic must be deposited proximal to the splitting of the sciatic nerve. By placing the probe at the popliteal crease and scanning the leg in the cephalad direction,both the tibial and peroneal components of the sciatic nerve can be visualized separately as they coalesce to form the sciatic nerve

OBJECTIVES

Primary objective:

  • To determine the duration of effect of us guided popliteal sciatic nerve block with dose of 15 ml 2% lignocaine adrenaline with additive buprenorphine 0.5 ml with 5 ml normal saline and 15 ml of 2%lignocaine adrenaline with clonidine 0.5 ml and 5 ml normal saline to find out the onset and duration of anaesthesia

Secondary objective:

  • To determine the requirement of tramadol as rescue analgesia in the first 24 hours

Study design

This study was designed as a Double blinded,Randomised control study

SAMPLE SIZE

Total sample size=68

Group A=34

Group B =34

INCLUSION CRITERIA

  • Patient coming for below knee surgeries with ASA grade1, grade 2, grade 3

EXCLUSION CRITERIA

  • Patient refusal
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Patient with psychiatric disorders

METHODOLOGY

  • All patients will be premedicated with alprazolam 0.5 mg orally.Heart rate, noninvasive blood pressure, and peripheral O2 saturation will be continuously monitored during surgery and in the postoperative period
  • Place the patient in the lateral position with the operative leg supported below the knee.
  • Using high frequency ultrasound,a 23-G quincke needle will be introduced at least 7-cm superior to the popliteal crease
  • With the probe parallel to the popliteal crease and at a level proximal to the nerve split, insert the needle at the lateral aspect of the probe and advance it toward the nerve. After the sciatic sheath is penetrated and the nerve is stimulated, inject 15mL of 2% xylocaine with adrenaline and buprenorphine 0.5ml in Group A and inject 15mL of 2% xylocaine with adrenaline and Clonidine 0.5ml

REFERENCES

  1. López-González JM, López-Álvarez S, Jiménez Gómez BM, Areán González I, Illodo Miramontes G, Padín Barreiro L. Ultrasound-guided transversalis fascia plane block versus anterior transversus abdominis plane block in outpatient inguinal hernia repair. Rev Esp Anestesiol Reanim. 2016 Nov;63(9):498-504. English, Spanish. doi: 10.1016/j.redar.2016.02.005. Epub 2016 Apr 8. PMID: 27067036.

  2. Rahimzadeh P, Faiz SH, Imani F, Jahromi MR. Comparison between ultrasound guided transversalis fascia plane and transversus abdominis plane block on postoperative pain in patients undergoing elective cesarean section: a randomized clinical trial. Iran Red Crescent Med J. 2018 Sep 1;20(9):7.

  3. Kadam RV, Field J. Ultrasound-guided continuous transverse abdominis plane block for abdominal surgery. Journal of anaesthesiology, clinical pharmacology. 2011 Jul;27(3):333.

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 75.00 Year(s)(—)
性别
All

入选标准

  • Patients coming for below knee surgeries coming for both elective and emergency with American society of Anaesthesiologist(ASA) grade 1,grade 2,grade 3.

排除标准

  • Patient refusal Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Patient with psychiatric disorders.

结局指标

主要结局

To compare the duration of analgesia

时间窗: First 24 hours

次要结局

  • To compare the additional analgesic requirement in first 24 hours(First 24 hours)

研究者

发起方
Chettinad hospital and research institute
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vinith kumar R

Chettinad academy of Research and Education Chettinad health city

研究点 (1)

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