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临床试验/NCT05864872
NCT05864872已完成不适用

What is the Best Approach for Blocking Intercostobrachial and Medial Brachial Cutaneous Nerves in the Upper Arm Surgery? Ultrasound as an Alternative to Blind Infiltration

Olfa kaabachi, MD1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023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
已完成
发起方
入组人数
140
试验地点
1
主要终点
tourniquet pain

研究概览

简要总结

Brachial plexus block (BPB) alone, whether performed at the axilla or more proximally, does not provide sufficient anesthesia for the skin of the medial upper arm and elbow, because thoracic roots contribute to the innervation of these areas.

For surgery of the upper arm, the brachial plexus block needs to be completed by the Medial Brachial Cutaneous nerve (MBCN) and the Intercostobrachial nerve (ICBN) nerve blocks.

The ICBN is not part of the brachial plexus; it usually originates from the lateral branch of the second intercostals nerve (T2). The MBCN and the ICBN are often interconnected. In the axilla, they are separated from the brachial plexus by the brachial fascia. Therefore, when an axillary brachial plexus block (ABPB) is performed, the local anesthetic solution may be prevented from spreading toward the MBCN and ICBN.

These nerves are classically anesthetized by raising a subcutaneous wheel of local anesthetic spanning the entire width of the medial aspect of the arm at the level of the axilla, usually from anteriorly to posteriorly. The failure rate of this blind infiltration procedure has never been quantified in the literature. Traditional teaching suggests that the ICBN should be blocked to prevent tourniquet pain. Lanz et al (1) showed that BPB, whether performed to the axilla or more proximally, rarely extend to the ICBN (10% of cases). However, recent literature shows differences in opinion on the role of an ICBN/MBCN blocks in preventing tourniquet pain. Ultrasound guided ABPB is sufficient to provide anaesthesia for tourniquet even during prolonged ischemia. However, to ensure prevention of tourniquet discomfort a multiple injection technique that include musculocutaneous blockade should be preferred (2). The overall incidence of tourniquet pain in the setting of an effectively dense supraclavicular brachial plexus block for surgical anesthesia was low, even without the addition of an ICBN block. This tourniquet pain can be easily managed with small increases in systemic analgesics (3). However, in Magazzeni Ph et al (4) study, ultrasound-Guided Block of ICBN and MBCN was associated to a better sensory block and a less painful tourniquet compared to conventional block.

The optimal access for an ultrasound guided block of the MBCN and the ICBN nerves is not yet known.

详细描述

  • Routine monitoring was applied, and intravenous access secured for each patient.
  • Sedation with 2 mg of midazolam was administrated
  • 2L of O2 were administrated through nasal cannula
  • Physical separation between the patient and the anesthesiologist was established before the block procedure
  • Ultrasound images were acquired with SonoSite(Turbo M), and a linear ultrasound probe (6-13 MHz) was used.
  • Nerve blocks were performed with 100mm 22-gauge needles (Braun), in an awake patient through ideally a single skin puncture.
  • In both groups, the median, radial, ulnar, musculocutaneous, and medial antebrachial cutaneous nerves were blocked with a total of 30 mL of a mixiture of 0.5 %bupivacaine + 1% lilocaine
  • Intraoperatively, if the tourniquet was painful, fentanyl and additional midazolam dose were administered.

Patients are allocated to one of the two groups:

Group C In patients allocated to the conventional group, 3 to 6 mL of bupivacaine (at the discretion of the anesthesiologist) was infiltrated blindly subcutaneously at the same level of the axilla in the anteroposterior direction prior to complete needle withdrawal.

Group U In patients allocated to the USG group, the needle was redirected, and between 1 and 2 mL of bupivacaine was injected around each visible nerve branch (MBCN and ICBN); if the nerve branches were not visible, 5 mL of the local anesthetic was injected (or less volume if the nerves appeared during the injection), in the subcutaneous area located above the brachial fascia, with a posterior direction, toward the latissimus dorsi muscle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient belonged to (ASA) physical status 1 2 3, aged more than 18 years old and scheduled for surgery of the upper limb (hand, forearm, elbow, and anteromedial and posteromedial arm).

排除标准

  • •Patients refusal, any allergy to the study drugs, local infection at any of the puncture sites, any coagulation disorder, or any neurological or psychological problem which may have affected proper subjective interpretation of the results.

研究组 & 干预措施

Ultrasound group

Experimental

after blockage of the principal four nerves of the brachial plexus, the needle was redirected, and between 1 and 2 mL of bupivacaine was injected around each visible nerve branch (Intercostobrachial and Medial Brachial Cutaneous ); if the nerve branches were not visible, 5 mL of the local anesthetic was injected (or less volume if the nerves appeared during the injection), in the subcutaneous area located above the brachial fascia, with a posterior direction, toward the latissimus dorsi muscle.

干预措施: axillary brachial plexus block (Procedure)

conventional group

Active Comparator

after blockage of the principal four nerves of the brachial plexus, 3 to 6 mL of bupivacaine (at the discretion of the anesthesiologist) was infiltrated blindly subcutaneously at the same level of the axilla in the anteroposterior direction prior to complete needle withdrawal

干预措施: axillary brachial plexus block (Procedure)

结局指标

主要结局

tourniquet pain

时间窗: during surgery

The proportion of patients pain free when inflating tourniquet.

次要结局

  • durationof ultrasound image(during ultrasound procedure)
  • Quality of ultrasound images(during ultrasound procedure)
  • sensitive block(5, 10, 15 and 20 minutes after performing the block)
  • rescue sedetion(during surgery)

研究者

发起方
Olfa kaabachi, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Olfa kaabachi, MD

MD

University Tunis El Manar

研究点 (1)

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