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
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
Dr Ganpat Prasad
Sanjay Gandhi Post graduate institute of medical science
