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临床试验/NCT07326943
NCT07326943招募中不适用

Minimum Effective Dose of Ropivacaine 0.5% for Ultrasound-guided Interscalene Block Targeting the C7 Nerve Root in Hand and Forearm Surgery

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
Assessment of blocking effect

研究概览

简要总结

Inter muscular groove brachial plexus block is a commonly used peripheral nerve block technique in clinical practice, commonly used for anesthesia and analgesia in clavicle, shoulder, and humeral surgeries. The classic ultrasound-guided intermuscular groove block also involves puncturing the needle to the level of the C5/C6 anterior branch for drug injection. After injection, local anesthetics mainly wrap around C5, C6, and some C7 nerve roots. Therefore, intermuscular groove block is mainly used for shoulder, humerus, and clavicle surgery. Due to incomplete ulnar block, it is not recommended for surgery on the elbow joint and its distal end.Scholars have found that using C5 as the puncture target to implement intermuscular groove block and administering 10ml of 0.75% ropivacaine, the success rate of ulnar nerve block is 19%. The success rate of ulnar nerve block with C6 as the puncture target was 93% when 10ml of 0.75% ropivacaine was administered. This suggests that blockade methods closer to the tail muscle groove on the tail side have a higher success rate for blocking the C7, C8, and T1 nerve roots. In our clinical work, the investigators found that when performing intermuscular groove block with C7 nerve root as the puncture target, local anesthetics not only stably wrap around C7 nerve root, but also spread to wrap around C5 and C6 nerve roots on the head side, and spread to the deep surface of the brachial plexus trunk on the tail side. Local anesthetic diffusion can also be seen in some patients at the brachial plexus bundle in the intercostal space. From the perspective of local anesthetic diffusion patterns, intermuscular groove block targeting the C7 nerve root may cover the anterior branches of C5, C6, C7, C8, and T1 nerve roots, achieving complete brachial plexus block. Preliminary clinical practice suggests that C7 intermuscular groove block can be used for forearm and hand surgery. Successful C7 intermuscular groove block relies on the diffusion and wrapping of local anesthetics around the anterior branches of C5, C6, and C7 nerve roots, as well as the inferior trunk of the brachial plexus (or the anterior branches of C8 and T1 nerve roots).Therefore, the investigators designed this study to determine the amount of local anesthetic required to achieve stable forearm and hand block during C7 intermuscular groove block.

详细描述

Inter muscular groove brachial plexus block is a commonly used peripheral nerve block technique in clinical practice, commonly used for anesthesia and analgesia in clavicle, shoulder, and humeral surgeries. Intermuscular groove block is achieved by injecting local anesthetics between the anterior and middle scalene muscles in order to block the anterior branches of the cervical nerve that pass through this gap, including the anterior branches of the cervical 5 (C5), cervical 6 (C6), and cervical 7 (C7) spinal nerves. The classic technique of intermuscular groove block involves puncturing the thyroid cartilage horizontally into the intermuscular groove. This area is roughly equivalent to the level of the anterior branch of the C5/C6 nerve root. The classic ultrasound-guided intermuscular groove block also involves puncturing the needle to the level of the C5/C6 anterior branch for drug injection. After injection, local anesthetics mainly wrap around C5, C6, and some C7 nerve roots. According to the range of spinal nerve innervation, its blocking range is located in the shoulder, the anterior, posterior, and lateral sides of the upper arm, the anterior, posterior, and lateral sides of the forearm, and the two and a half fingers on the radial side. Therefore, intermuscular groove block is mainly used for shoulder, humerus, and clavicle surgery. Due to incomplete ulnar block, it is not recommended for surgery on the elbow joint and its distal end.Scholars have found that using C5 as the puncture target to implement intermuscular groove block and administering 10ml of 0.75% ropivacaine, the success rate of ulnar nerve block is 19%. The success rate of ulnar nerve block with C6 as the puncture target was 93% when 10ml of 0.75% ropivacaine was administered. This suggests that blockade methods closer to the tail muscle groove on the tail side have a higher success rate for blocking the C7, C8, and T1 nerve roots. In our clinical work, the investigators found that when performing intermuscular groove block with C7 nerve root as the puncture target, local anesthetics not only stably wrap around C7 nerve root, but also spread to wrap around C5 and C6 nerve roots on the head side, and spread to the deep surface of the brachial plexus trunk on the tail side. Local anesthetic diffusion can also be seen in some patients at the brachial plexus bundle in the intercostal space. From the perspective of local anesthetic diffusion patterns, intermuscular groove block targeting the C7 nerve root may cover the anterior branches of C5, C6, C7, C8, and T1 nerve roots, achieving complete brachial plexus block. In the preliminary exploratory clinical work, the patient underwent C7 nerve root intermuscular groove brachial plexus block. Through sensory testing, it was found that the musculocutaneous nerve, medial forearm nerve, radial nerve, median nerve, and ulnar nerve could all be stably blocked, and the forearm and hand surgeries were successfully completed under nerve block. Preliminary clinical practice suggests that C7 intermuscular groove block can be used for forearm and hand surgery. Successful C7 intermuscular groove block relies on the diffusion and wrapping of local anesthetics around the anterior branches of C5, C6, and C7 nerve roots, as well as the inferior trunk of the brachial plexus (or the anterior branches of C8 and T1 nerve roots).Therefore, the investigators designed this study to determine the amount of local anesthetic required to achieve stable forearm and hand block during C7 intermuscular groove block.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range: 18-60 years old
  • BMI between 18 and 30kg/m2
  • Patients undergoing hand or forearm surgery
  • Sign informed consent form

排除标准

  • Refusal to participate in the experiment
  • Merge peripheral nerve diseases
  • Lidocaine and ropivacaine allergy
  • Pregnant women
  • Obstructive or restrictive lung disease
  • Coagulation dysfunction
  • Long term use of opioid drugs
  • Infection, tumor or surgical history at the puncture site

研究组 & 干预措施

Deceasing

Experimental

Brachial plexus block with decreasing dose. Real time ultrasound-guided intermuscular brachial plexus block anesthesia targeting the C7 nerve root.

干预措施: Ultrasound guided intermuscular groove block targeting the C7 nerve root (Procedure)

similar

Experimental

Brachial plexus block, with similar doses. Real time ultrasound-guided intermuscular brachial plexus block anesthesia for C7 nerve roots

干预措施: Ultrasound guided intermuscular groove block targeting the C7 nerve root (Procedure)

结局指标

主要结局

Assessment of blocking effect

时间窗: From the completion of nerve block to the 30th minute after block

Starting from the completion of the nerve block, an independent evaluator (unaware of the dosage used) will test and record the block effect at 10, 20, and 30 minutes after the block. The block effect will be judged based on the effect at 30 minutes. Conduct sensory tests on the skin innervated by various nerves using ice cubes. Use a 3-point numerical scale (0=normal cold sensation, no obstruction; 1=partial cold sensation, partial obstruction; 2=no cold sensation, complete obstruction). Radial nerve, median nerve, ulnar nerve, musculocutaneous nerve, and medial forearm cutaneous nerve. Evaluate the degree of motor block through specific exercise activities (0=normal activity, 1=partial block, 2=complete block). Patients who are fully awake or have been administered an appropriate amount of sedatives, maintain spontaneous breathing, and successfully complete the surgery are considered to have successful blockade (i.e. positive reaction).

次要结局

  • Diaphragmatic muscle movement status(From the completion of nerve block to the 30th minute after block)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hua Zheng

Head of the Anesthesiology Department

Huazhong University of Science and Technology

研究点 (1)

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