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临床试验/CTRI/2025/03/083420
CTRI/2025/03/083420尚未招募不适用

Comparative Evaluation of Post-operative Analgesic Efficacy of single injection with adjuvant versus intermittent bolus technique in infraclavicular brachial plexus block in patients undergoing surgery below distal humerus: A Prospective randomized observer blinded study

SGPGIMS LUCKNOW1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月23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
Total fentanyl consumption in 48 hrs after surgery by use of IV Patient Controlled Analgesia

研究概览

简要总结

This study aims to compare the post-operative analgesic efficacy of single injection with adjuvant

versus intermittent bolus technique in infraclavicular brachial plexus block (ICB) for patients

undergoing surgery below the distal humerus. The advantages associated with the ICB like high

success rates, low complication risks, and adequate analgesia making it more preferable for upper

extremity surgery. The primary objective of the study is to compare total fentanyl consumption in

48 hours after surgery using IV Patient Controlled Analgesia and the secondary objective

comprises of static and dynamic pain assessment by Mean NRS till 48 hours, patient satisfactory

score, quality of recovery score, total rescue analgesia used in 48 hours, and postoperative nausea

and vomiting. Study design is a prospective randomized observer-blinded study, with patients

randomly allocated using block randomization. It will take place at Apex Trauma Center

SGPGIMS Lucknow, with a duration of 1.5 years for data collection. Inclusion criteria include

patients aged 18-70 years, ASA grade I and II, undergoing surgery below the distal humerus and

provided with informed and written consent. Exclusion criteria include ASA grade III and IV, BMI

35 kg/m2, polytrauma, known allergies to local anesthetics etc. Methodology followed in the

study involves preparing the patient, performing ultrasound-guided infraclavicular block, and

using specific equipment for local anesthetic administration. Patients in the single injection group

(SIG) will receive 25ml of (0.5% bupivacaine with 4mg of dexamethasone as an adjuvant), while

those in the intermittent bolus group (IBG) will receive 25ml of (0.5% bupivacaine). Patients in

both groups will receive postoperative analgesia via IV Patient Controlled Analgesia and 1gm

paracetamol every 6 hourlies as a part of multimodal analgesia for pain control. estimation of the

sample size will be based on reported fentanyl consumption in a similar study, with 40 patients

planned for each group. Statistical analysis will include comparing means/medians between groups

using various tests like t-tests or Mann-Whitney U tests for continuous variables and Chisquare/Fisher exact tests for categorical variables. Ethical considerations include obtaining

approval from the institutional ethics committee and written informed consent from patients. This

study will provide in depth information on the effectiveness of various ICB methods that may

improve postoperative pain management in patients undergoing surgery below the distal

humerus

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor 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

  • Patient who will give written and informed consent Patient undergoing surgery below distal humerus.
  • Patients belonging to ASA grade I and II.

排除标准

  • Patient refusal.
  • ASA grade III and IV BMI 35 kg/m2 Patient with polytrauma Patient who will have known allergy and intolerance to local anesthetics& having active skin infection.
  • Patient with cognitive impairment, delirium, dementia and severe hearing loss Coexisting coagulopathy or anticoagulant or antiplatelet treatment that would be a contraindication to regional anesthesia.
  • Patient having pre existing neurological deficit in forearm.

结局指标

主要结局

Total fentanyl consumption in 48 hrs after surgery by use of IV Patient Controlled Analgesia

时间窗: 48 hours

次要结局

  • Static & dynamic pain assessment by Mean NRS (Numeric Rating Scale)at 2hr,4hr,12hr,18hr,24hr,30hr,36hr,42hr & 48hr till 48 hrs(Patient satisfactory score at 48hrs)

研究者

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

Dr Ganpat Prasad

Sanjay Gandhi Post graduate institute of medical science

研究点 (1)

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