Minimal Effective Volume 90% for Double-injection Costoclavicular Block

Официальное название

Minimum Effective Volume of Lidocaine for Double-Injection Ultrasound-Guided Costoclavicular Block

Обзор

In 2020, a trial demonstrated that a 2-injection technique constitutes the optimal method for the costoclavicular block. This study aims to determine the minimum amount of medication required to achieve a successful double-injection costoclavicular nerve. Block dose assignment will be done using an up-and-down sequential method, called the Biased Coin Design (BCD). The double-injection technique for US-guided costoclavicular block consists in depositing two thirds of the LA volume in the deep compartment (to anesthetize the posterior and medial cords), and one third of the injectate in the superficial compartment (to anesthetize the lateral cord). The ED90 will be calculated using isotonic regression with a 95% confidence interval derived by bootstrapping.

Подробное описание

With the approval of the ethics committee of McGill University Health Centre, a total of 60 patients undergoing upper extremity surgery (elbow or below elbow) will be recruited.

The costoclavicular block will be performed under direct US vision until the tip is between the medial cord and the axillary artery. Two thirds of the volume of LA will be injected in this first location. Subsequently, the needle will be advanced until its tip is positioned next to the lateral cord. The remaining third of the LA volume will be injected in this second location.

Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design. The first subject recruited will receive a total of 30 mL of lidocaine 1.5 % with epinephrine 1: 200 000. Injection will be carried out by slow increments (5 mL) with negative aspiration between each increment.

The assignment of each subsequent dose will be based on the response of the previous patient as follows: if the previous patient did not have a successful block, the patient will receive the next higher dose, which is the previous dose incremented by 3.0 ml (i.e., an increment of 2.0 mL between the medial cord and the axillary artery, and an increment of 1.0 mL next to the lateral cord). If the previous patient had a successful block, the patient will be randomized to either receive the next lower dose, which is the previous dose decremented by 3.0 ml (i.e., a decrement of 2.0 mL between the medial cord and the axillary artery, and a decrement of 1.0 mL next to the lateral cord), with a probability b = 0.11, or to receive the same previous dose, with a probability 1 - b = 0.89. These are the probabilities required for assigning doses under the BCD for estimating ED90. A maximal dose of 40 mL will not be exceeded to avoid LA toxicity. If the previous patient did not respond and had been given the maximal dose the patient will also get the maximal dose. As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure.

A research assistant will prepare and administer the injectate using syringes connected to the block needle. The operator and the patient will be blinded to the volume injected.

After LA injection at the second site, a catheter will be advanced 3 cm past the needle tip and secured to the skin. The purpose of the catheter is to allow LA supplementation for unsuccessful blocks, LA reinjection for lengthy surgical procedures or postoperative LA infusion for pain control.

The primary outcome is success rate which is defined as a minimal composite score of at least 14 points (out of a maximum of 16) is achieved at 30 minutes. The ED90 will be calculated using isotonic regression with a 95% confidence interval derived by bootstrapping .

Вмешательства

• Процедура Ultrasound-guided double-injection costoclavicular nerve block with same previous volume
  ultrasound-guided double-injection costoclavicular nerve block with the same volume used in the previous successful block
• Процедура Ultrasound-guided double-injection costoclavicular nerve block with lower volume
  Ultrasound-guided double-injection costoclavicular nerve block with lower volume than the previous successful block

Первичные конечные точки

• Success rate [Срок оценки: 30 minutes]

Вторичные конечные точки (7)

• Operator level of experience [Срок оценки: 1 hour before surgery]
• The number of needle passes [Срок оценки: 1 hour before surgery]
• Block performance time [Срок оценки: 1 hour before surgery]
• Block onset time [Срок оценки: 1 hour before surgery]
• Total anesthesia-related time [Срок оценки: 1 hour before surgery]
• Intensity of pain during block procedure [Срок оценки: 1 hour before surgery]
• Phrenic nerve block [Срок оценки: 1 hour after arrival to post anesthesia care unit]

Критерии участия

Критерии включения

• Age between 18 and 70 years
• American Society of Anesthesiologists classification 1-3
• Body mass index between 20 and 30

Критерии исключения

• Adults who are unable to give their own consent
• Pre-existing neuropathy (assessed by history and physical examination)
• Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
• Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
• Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
• Allergy to LA
• Pregnancy
• Prior surgery in the infraclavicular region
• Chronic pain syndromes requiring opioid intake at home

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Montreal General Hospital — Montreal

Публикации

• Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x. PMID 11890313
• Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60. PMID 9192462
• Saranteas T, Finlayson RJ, Tran DQ. Dose-finding methodology for peripheral nerve blocks. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):550-5. doi: 10.1097/AAP.0000000000000157. PMID 25304484
• Layera S, Aliste J, Bravo D, Fernandez D, Garcia A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14. PMID 31941792
• Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566. PMID 28157792
• Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available. PMID 25899958

Идентификаторы

NCT: NCT07374952 · COSTOCLAV DF 2026-11651

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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