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NCT Number: NCT07374952

Minimal Effective Volume 90% for Double-injection Costoclavicular Block

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location status: Recruiting

Location contact

Julián Aliste, MD

CONTACT

[email protected]

5149341934 ext. 43261

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Success rate

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Operator level of experience

    Time frame: 1 hour before surgery

    expert vs. trainee

  2. The number of needle passes

    Time frame: 1 hour before surgery

    The number of times the needle had to be withdrawn by ≥1 cm before redirecting to achieve the final position for local anesthetic injection.

  3. Block performance time

    Time frame: 1 hour before surgery

    Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)

  4. Block onset time

    Time frame: 1 hour before surgery

    Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in primary outcome.

  5. Total anesthesia-related time

    Time frame: 1 hour before surgery

    Sum of: 1- the performance time and 2- the onset time

  6. Intensity of pain during block procedure

    Time frame: 1 hour before surgery

    Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.

  7. Phrenic nerve block

    Time frame: 1 hour after arrival to post anesthesia care unit

    presence of dyspnea in postanesthetic care unit

Other outcomes

  1. Incidence of nerve block side effects

    Time frame: From skin anesthesia to 60 minutes after the nerve block

    The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, pneumothorax, or local anesthetic systemic toxicity after the nerve block.

Study contacts

Contact information is provided by the study sponsor or research team.

Julián Aliste, M.D.

CONTACT

[email protected]

+15149341934-43795

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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