Median Effective Volume of 0.5% Ropivacaine for Ultrasound-Guided Single-Injection Sub-arterial Axillary Brachial Plexus Block in Extreme Arm Abduction: A Dose Finding Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To determine the Median Effective Dose of 0.5% Ropivacaine required to produce a successful USG-guided single-injection subarterial Axillary block with arm in extreme abduction for providing surgical anesthesia in 95% of the patients (ED95)
研究概览
简要总结
Ultrasound guided Axillary Brachial plexus Block serves as an effective anaesthetic technique for surgeries below the elbow, facilitating postoperative pain management, reducing recovery duration, and promoting early discharge of patients who undergo outpatient procedures. The close proximity of musculocutaneous nerve to axillary artery in extreme arm hyperabduction presents the opportunity to block all four nerves(radial, ulnar, median, and musculocutaneous) with a single sub arterial injection (at 6 o’clock position with respect to axillary artery), as opposed to the previously utilized conventional methods. A single sub arterial injection is known to reduce the number of needle passes, the block performance time, and the risk of nerve needle contact, resulting in decreased potential for neural injury and paraesthesia. Literature is sparse with regards to the median effective dose of local anesthetic (0.5% ropivacaine) required to produce an effective ultrasound guided axillary brachial plexus block, with the arm in extreme abduction, using a single sub-arterial injection, thus enabling blocking all four nerves. We thus conceptualized this dose finding study. The volume of the drug to be injected will be determined by up and down sequential allocation study design of binary response variables. An initial single sub arterial injection of 24 mL of 0.5% Ropivacaine (1 dose level below the presumed target) will be administered in slow increments while keeping axillary artery in the center. If the first person receiving the initial volume (24mL) of local anaesthetic achieves a successful block, then the volume of local anaesthetic to be given to the next patient will be decreased by 2mL, whereas block failure will result in an increase of volume by 2mL for next patient. In order to avoid local anesthetic toxicity, we did not exceed the volume of local anesthetic to more than 40ml of 0.5% Ropivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA 1 or 2 BMI 18 to 30kg/m2 scheduled to undergo forearm and hand surgeries under ultrasound-guided Axillary brachial plexus block.
排除标准
- •Coagulopathy Local Site Infection Anticoagulant therapy Allergy to Local Anaesthetics Preexisting motor or sensory deficit in the operative limb Denial of permission to participate in the study.
结局指标
主要结局
To determine the Median Effective Dose of 0.5% Ropivacaine required to produce a successful USG-guided single-injection subarterial Axillary block with arm in extreme abduction for providing surgical anesthesia in 95% of the patients (ED95)
时间窗: 30 minutes following block administration
次要结局
- Incidence of block success(30 minutes following block administration)
- Block performance time(at the time of block administration)
- Number of needle passes(at the time of block administration)
- Block onset time(every 5 minutes till 30 minutes following block administration)
- Block duration / Time to first request for rescue analgesia(24 hours)
- Distance between the Musculocutaneous nerve and Axillary Artery(at the time of block administration)
