Efficacy of Combined US-Guided Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA With Fentanyl on Preventing Tourniquet Pain in Forearm Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of tourniquet pain
研究概览
简要总结
The etiology of tourniquet pain is complex, and the study team hypothesizes that blocking with Interscalene brachial plexus block (ISBPB) is more efficient in decreasing the incidence of tourniquet pain in comparison with other techniques.
As there is a paucity of studies that evaluate the effect of intercostobrachial nerve (ICBN) block and ISBPB and Patient-Controlled Analgesia (PCA) with a supraclavicular brachial plexus block (SCBPB) on tourniquet pain in forearm surgery, Therefore, we established this randomized study to compare ISBPB and ICBN and PCA with fentanyl with SCBPB in terms of the incidence and severity of tourniquet pain in patients undergoing forearm surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged more than 18 years,
- •ASAI-III patients
- •scheduled to undergo orthopedic or plastic surgery distal to the elbow with an anticipated tourniquet duration greater than 45 min.
- •desiring regional anesthesia as the primary anesthetic.
排除标准
- •Contraindication to regional anesthesia.
- •Allergy to local anesthetics.
- •Primary block failure.
- •If patients desired deep intraoperative sedation.
- •Clinically significant cognitive impairment.
研究组 & 干预措施
interscalene analgesia (Group ISBPB)
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
The C5 to C7 or C5 to C8 nerve roots between the anterior scalene and middle scalene muscles will be visualized in the absence of the subclavian artery and 10 mL 0.125% bupivacaine will be injected around the nerve roots of the brachial plexus. The needle trajectory will be adjusted to facilitate the even distribution of the local anesthetic around each nerve root.
干预措施: bupivacaine, midazolam (Drug)
The intercostobrachial nerve block ( Group ICBN)
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
The ICBN block will be performed with 10 mL of 0.5% bupivacaine in the plane deep to the pectoralis minor and/or serratus anterior muscle over the second and third intercostal space.
干预措施: bupivacaine, midazolam (Drug)
Patient-Controlled Analgesia (Group PCA)
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
干预措施: bupivacaine, midazolam (Drug)
结局指标
主要结局
The incidence of tourniquet pain
时间窗: 2 hours
The incidence of tourniquet pain will be assessed by the patient's VAS score. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.
次要结局
- Patients' satisfaction(24 hours)
- Hemodynamics(2 hours)
- The incidence of adverse reactions(2 hours)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University