Skip to content

Effective lidocaine volume for a double-injection costoclavicular brachial plexus block

Minimum effective volume of lidocaine for double-injection ultrasound-guided costoclavicular block

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16060312
Enrollment
60
Registered
2025-11-11
Start date
2025-11-17
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial plexus nerve block for upper extremity surgery Surgery

Interventions

Patients undergoing upper extremity surgery (elbow and below) under a double-injection costoclavicular brachial plexus block will be assigned to a predetermined volume of adrenalized 1.5% lidocaine.

Sponsors

McGill University Health Centre
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Surgery of the distal upper extremity under brachial plexus block 2. Age between 18 and 70 years 3. American Society of Anesthesiologists classification 1-3 4. Body mass index between 20 and 30 kg/m²

Exclusion criteria

Exclusion criteria: 1. Adults who are unable to give their own consent 2. Pre-existing neuropathy (assessed by history and physical examination) 3. 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) 4. Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood workup up i.e. creatinine =100) 5. Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood workup up i.e. transaminases =100) 6. Allergy to local anesthetics 7. Pregnancy 8. Prior surgery in the infraclavicular region 9. Chronic pain syndromes requiring opioid intake at home

Design outcomes

Primary

MeasureTime frame
Success rate (binary outcome): dose-response data will be used to estimate the minimum effective volume of LA required to successfully anesthetize the brachial plexus in 90% of patients. Success definition: Using a previously reported 16 point sensorimotor scale for musculocutaneus, radial, median and ulnar nerves. A block will be considered successful if, at 30 minutes (after injection), a composite score of at least 14 points (out of a maximum of 16) is obtained. This score has been proven to provide a reliable estimate of surgical anesthesia. Sensory blockade will be graded with a 3-point scale using a cold test to each nerve sensory regions: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot fee touch) (3). The cold test will be applied with light touch to avoid confusion with deep pressure sensation. Motor blockade will also be graded on a 3-point scale by elbow flexion (musculocutaneous), thumb abduction (radial), thumb opposition (median) and thumb adduction (ulnar).: 0 = no block, 1 = paresis, 2 = paralysis (3).

Secondary

MeasureTime frame
1. Operator's level of experience (binary): expert vs trainee (expert defined as an experienced operator of a minimum of 60 costoclavicular blocks) 2. Number of needle passes (count): after needle insertion, any needle adjustment requiring 10 mm retraction will be considered an extra pass 3. Performance time (seconds): time necessary to guide the needle to the desired locations 4. Patient discomfort measured using a Visual Analog Scale (VAS) during the block: 0 = minimum discomfort and 10 = maximum discomfort 5. Demographic data: 5.1. Sex (binary): male/female 5.2. Age (years) 5.3. Weight (kilograms) 5.4. Height (centimeters) 5.5. Type of surgery (count): elbow/forearm/wrist/hand 6. Side effects: 6.1. Vascular puncture (binary): yes/no (ultrasound evidence of vascular puncture or blood reflux trough block needle) 6.2. Hematoma at the site of puncture (binary): yes/no (ultrasonographic or clinical evidence of hematoma) 6.3. Toxic effects of LA (binary): yes/no (presence of clinical signs of systemic toxicity to local anesthetics: tinnitus, perioral paresthesia, confusion, seizures, ECG alterations) 6.4. Hoarseness (binary): yes/no 6.5. Phrenic nerve block (count): normal/paresis/paralysis (by ultrasound-assessed excursion change from baseline before block, excursion decrease >25% = paresis, excursion decrease >75% = paralysis) 6.6. Horner’s syndrome (binary): yes/no ( clinical signs)

Countries

Canada

Contacts

Public ContactJulián Aliste
julian.aliste@mcgill.ca+1 (0)514 934 1934 ext 43261

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026