Determining the Minimal Effective Lidocaine Volume for Double-Injection Ultrasound-Guided Costoclavicular Nerve Block in Adults
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-07-07
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the minimum effective volume of lidocaine needed for a successful double-injection ultrasound-guided costoclavicular nerve block in patients undergoing upper extremity surgery below the elbow. This phase 4 study builds on prior evidence supporting the double-injection technique and aims to determine the dose that achieves a 90% success rate using a sequential dose assignment method called the Biased Coin Design.
Participants will receive the nerve block with lidocaine 1.5% with epinephrine injected in two locations near specific nerves under ultrasound guidance. The dose for each patient depends on the previous patients response, adjusting up or down in increments, with a maximum volume of 40 mL to avoid toxicity. The study includes randomization to either the same successful dose or a lower dose. A catheter is placed to allow additional anesthetic if needed.
During the study, patients will be assessed for block success 30 minutes after injection using a composite score. Other measures include operator experience, needle passes, block performance and onset times, anesthesia time, pain intensity during the procedure, and phrenic nerve block occurrence. The study involves blinding of operators and patients, with a total enrollment of 60 patients and completion planned by the end of 2026.
CONDITIONS
Brief Title
Minimal Effective Volume 90% for Double-injection Costoclavicular Block
Research Team
J
Julián Aliste, M.D.
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
Age between 18 and 70 years
American Society of Anesthesiologists classification 1-3
Body mass index between 20 and 30
You will not qualify if you...
Adults who are unable to give their own consent
Pre-existing neuropathy (assessed by history and physical examination)
Coagulopathy (assessed by history, physical examination, and blood work if needed)
Renal failure (assessed by history, physical examination, and blood work if needed)
Hepatic failure (assessed by history, physical examination, and blood work if needed)
Allergy to local anesthetics
Pregnancy
Prior surgery in the infraclavicular region
Chronic pain syndromes requiring opioid intake at home
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit
Treatment
Duration - Until 45 patients are enrolled with random dose assignments
Participants receive the ultrasound-guided double-injection costoclavicular nerve block with lidocaine at a dose determined by the previous patient's response. A catheter is placed for possible additional anesthetic if needed.
1 procedure visit
Follow-up
Duration - 30 minutes to 1 hour after block
Participants are monitored for block success and other outcomes such as pain levels and nerve effects after the procedure.
1 follow-up visit
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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