Clinical trial NCT03595514: Single Versus Double Injection Costoclavicular Block
Official title: A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Extremity Injury
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: University of Chile
First posted: 2018-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: OTHER

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.

Detailed description: The costoclavicular block (CCB) constitutes a relatively novel technique for infraclavicular brachial plexus blockade, whereby local anesthetics (LAs) are injected inside the costoclavicular space. In this location, the 3 cords of the brachial plexus are very tightly clustered together; this topography would theoretically result in a very swift brachial plexus block Unfortunately, in two recent trials comparing CCB and conventional infraclavicular brachial plexus block, the authors were unable to detect differences in success rate, onset times and LA requirement between the 2 methods. It could be speculated that the explanation resides in dynamic cord dispersion. With CCB, the initial needle target lies in the middle of the 3 cords of the brachial plexus. However, with LA injection, the cords can quickly migrate away from each other. Thus, the anatomical benefits conveyed by the initial compact topography may be lost.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Onset time of brachial plexus blockade
timeFrame: Within 30 minutes of block performance
Secondary outcomes:
measure: Performance time during the brachial plexus block
timeFrame: Intraoperative (During block performance)
measure: Number of needle passes
timeFrame: Intraoperative (During block performance)
measure: Procedure pain during the brachial plexus block
timeFrame: Intraoperative (During block performance)
measure: Incidence of surgical anesthesia
timeFrame: Thirty minutes after block performance
measure: Incidence of Adverse events
timeFrame: Intraoperative (During block performance)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: De Q Tran, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Layera S, Aliste J, Bravo D, Fernandez D, Garcia A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14.