Median effective volume of 0.5% ropivacaine for ultrasound guided multiple injection lateral sagittal infraclavicular plexus block: a dose finding study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The primary objective will be to estimate MEV90 for multiple-injection US-guided ICB. Volume assignment will be carried out using a biased coin design (BCD) up-and-down sequential method (UDM), where the volume administered to each patient will depend upon the response of previous patient. First subject will receive 21 ml based upon a previous study MEV50 of 19 ml in patients receiving ultrasound-guided LSIB with ropivacaine 7.5 mg/ml. based on the response of the previous patient. In case of failure, the next subject will receive a higher volume (0.5ml/ cord). If the previous patient had a successful block, the next subject will be randomized to a lower volume
研究概览
简要总结
Relatively large volumes of localanaesthetic (LA) and/or multiple injections are used to produce successful BPB.The minimum effective volume of LA needed for producing a multiple injectionLICF brachial plexus block is not known. Knowledgeof minimum effective volume is very important, so as to reduce the risk ofsystemic toxicity without affecting the efficacy of block. In a dose findingstudy done for single injection technique, the MEV in 95% of patients for anultrasound-guided LSIB with ropivacaine 7.5 mg/ml was estimated to be 31 ml(95% CI, 18–45 ml). Technique involved injection of drug in periarterial sectorfrom 3 to 11 o’clock and within 2cm of axis of axillary artery. We will inject selectivelysurround each sonographically imaged brachial plexus cord and define the local anesthetic required for multipleinjection technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with American Society of Anesthesiologists (ASA) physical status I-II patients, in the age group of 18-60 years, with a body mass index (BMI) between 18 and 30 kg.m-2, scheduled to undergo forearm and hand surgeries will be assessed for eligibility.
排除标准
- •Patients with local infection at the block site, coagulopathy, sepsis, BMI>30, allergy to local anesthetics, uncontrolled hypertension or ischemic heart disease, renal or hepatic dysfunction, pre-existing neurological deficits, prior surgery in the infraclavicular fossa, psychiatric illness, patients who failed to understand the scoring systems used in the study and patients who refused to give consent for the study will be excluded.
结局指标
主要结局
The primary objective will be to estimate MEV90 for multiple-injection US-guided ICB. Volume assignment will be carried out using a biased coin design (BCD) up-and-down sequential method (UDM), where the volume administered to each patient will depend upon the response of previous patient. First subject will receive 21 ml based upon a previous study MEV50 of 19 ml in patients receiving ultrasound-guided LSIB with ropivacaine 7.5 mg/ml. based on the response of the previous patient. In case of failure, the next subject will receive a higher volume (0.5ml/ cord). If the previous patient had a successful block, the next subject will be randomized to a lower volume
时间窗: 30 minutes after performance of block
次要结局
- Time to requirement of first bolus, mean pain scores at various time intervals(Baseline ie on shifting to PACU, 2hrs, 4hrs , 8hrs, 12hrs, 24hrs)