Selective truncal injection brachial plexus block for elbow and forearm surgeries- A dose finding study.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Success rate of Surgical Block MEV90 estimation
研究概览
简要总结
Selective Truncal Injection Brachial Plexus Block for Elbow and Forearm Surgeries A Dose Finding Study
This prospective, double-blind, dose-finding clinical study aims to evaluate the efficacy and safety of a selective truncal injection technique for brachial plexus block, specifically targeting the upper, middle, and lower trunks under ultrasound guidance, for patients undergoing elbow and forearm surgeries.
The primary objective is to determine the minimum effective volume (MEV90) of 0.5% bupivacaine required to achieve a successful block in 90% of patients. The study also assesses onset times, duration of sensory and motor block, patient and surgeon satisfaction, and monitors for procedure-related complications.
Patients aged 18–65 years, ASA physical status I–III, undergoing elective upper limb surgeries are included. Exclusion criteria involve factors like coagulopathy, allergy to local anesthetics, severe pulmonary disease, and BMI >35 kg/m². After ethical approval and consent, block performance is standardized using a high-frequency ultrasound to accurately identify and inject local anesthetic around the trunks of the brachial plexus.
A Dixon and Mood Up-and-Down design is used to adjust LA volume per patient response (success/failure), with Probit and logistic regression analysis employed to determine MEV90 and MEV95. A sample size of 44 to 66 patients is anticipated, considering dropout rates.
Success is defined as achieving a composite score of 20/20 (sensory + motor block) within 40 minutes without requiring conversion to another anesthetic technique.
The study contributes significantly to the refinement of regional anesthesia techniques, potentially improving patient outcomes and minimizing complications in upper limb surgeries.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patients aged between 18 and 65 years 2 Scheduled for elective upper limb surgery requiring brachial plexus block 3 Classified as American Society of Anesthesiologists (ASA) physical status I to III 4 Willing and able to provide written informed consent 5 Cooperative and able to communicate effectively during the procedure.
排除标准
- 未提供
结局指标
主要结局
Success rate of Surgical Block MEV90 estimation
时间窗: Block is assessed every 5 minutes till 40 min 0min 5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min
次要结局
- Sensory block onset time(Motor Block Onset Time)
研究者
Dr P Madhushree
Ballari institute of Medical Sciences and Research centre