Minimal Effective Volume 90% for Double-injection Costoclavicular Block

NCT07374952 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: COSTOCLAV DF 2026-11651
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Brachial Plexus Blocks; Lidocaine; Nerve Block; Dose Finding Study; Costoclavicular Block

Keywords

costoclavicular block; double injection technique; dose finding; nerve block; lidocaine

Outcome Measures

Primary Outcomes (1)

• Success rate

  The primary outcome is success rate evaluated by the sensorimotor block 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 sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, median, radial, and ulnar nerves. Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch. The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.

  30 minutes

Secondary Outcomes (7)

• Operator level of experience

  1 hour before surgery

• The number of needle passes

  1 hour before surgery

• Block performance time

  1 hour before surgery

• Block onset time

  1 hour before surgery

• Total anesthesia-related time

  1 hour before surgery

Other Outcomes (1)

• Incidence of nerve block side effects

  From skin anesthesia to 60 minutes after the nerve block

Study Arms (2)

Costoclavicular block with same previous successful volume

ACTIVE COMPARATOR

Patients randomized to this group will receive the same volume that was successful in the previous recruitment.

Procedure: Ultrasound-guided double-injection costoclavicular nerve block with same previous volume

Costoclavicular block with lower volume

EXPERIMENTAL

This group will be randomized to receive a fixed lower volume than the previously successful block.

Procedure: Ultrasound-guided double-injection costoclavicular nerve block with lower volume

Interventions

Ultrasound-guided double-injection costoclavicular nerve block with same previous volume PROCEDURE

ultrasound-guided double-injection costoclavicular nerve block with the same volume used in the previous successful block

Costoclavicular block with same previous successful volume

Ultrasound-guided double-injection costoclavicular nerve block with lower volume PROCEDURE

Ultrasound-guided double-injection costoclavicular nerve block with lower volume than the previous successful block

Costoclavicular block with lower volume

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Related Publications (6)

• 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 BACKGROUND

• Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.

  PMID: 9192462 BACKGROUND

• Saranteas T, Finlayson RJ, Tran DQH. Dose finding methodology for peripheral nerve blocks. Reg Anesth Pain Med. 2014;39:550-5.

  BACKGROUND

• Layera S, Aliste J, Bravo D, Fernández D, Garcia A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: A randomized comparison. Reg Anesth Pain Med. 2020;45:209-13.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Julián Aliste, M.D.

CONTACT

+15149341934-43795; julian.aliste@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A research assistant (a licensed anesthesiologist) will prepare the local anesthetic (lidocaine) solutions according to the sequential allocation. The operator, patient, and outcome assessor will remain blinded to the assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Lidocaine dose finding study with an up-and-down methodology

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share