Recruiting

Single vs. DoubleSingle Versus Double Injection Costoclavicular Block

Sponsor:

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

Code:

NCT03595514

Conditions

Upper Extremity Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Single injection

Double injection

lidocaine, bupivacaine, epinephrine, dexamethasone

Study Details

Brief summary:

In this trial, the objective is to compare single- and double-injection ultrasound-guided costoclavicular blocks. The rationale behind this idea is that a second local anesthetic injection, inside the costoclavicular space, may compensate for the dynamic cord dispersion seen with the single-injection technique. Thus the research hypothesis is that, compared to its single-injection counterpart, a double injection costoclavicular block will result in a shorter onset time.

Conditions

Upper Extremity Injury

Study ID

NCT03595514

Start date

Jul 30, 2018

Status verified date

Aug, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

age between 18 and 75 years
American Society of Anesthesiologists classification 1-3
body mass index between 18 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 thromboplastin 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 local anesthetic
pregnancy
prior surgery in the infraclavicular costoclavicular region
chronic pain syndromes requiring opioid intake at home

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Single Injection

Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus

experimental: Double Injection

Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus as well as at the intersection of the subclavian artery and the medial cord.

Interventions

Single injection

Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus

Double injection

lidocaine, bupivacaine, epinephrine, dexamethasone

lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone

Primary outcome measure

Onset time of brachial plexus blockade [ Time Frame: Within 30 minutes of block performance ]

Central Contacts and Locations

Central contacts

De Q Tran, MD, FRCPC

5149341934 de_tran@hotmail.com

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G-1A4

Contacts

De QH Tran, MD, FRCPC

(514)934-1934 de_tran@hotmail.com

Roderick J Finlayson, MD, FRCPC

(514)934-1934

More Information

Sponsor

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

Last update posted

Aug 16, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2018-08-16.