Single Versus Double Injection Costoclavicular Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block

Conditions
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Upper Extremity Injury

Intervention / Treatment
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* Other: Single injection
* Other: Double injection
* Drug: lidocaine, bupivacaine, epinephrine, dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Injection<br>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 | Other: Single injection<br>* 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<br>Drug: lidocaine, bupivacaine, epinephrine, dexamethasone<br>* lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone<br>|
| Experimental: Double Injection<br>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. | Other: Double injection<br>* 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.<br>Drug: lidocaine, bupivacaine, epinephrine, dexamethasone<br>* lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time of brachial plexus blockade | Onset until a minimal composite score of 14 points in a scale of 0-16 points, evaluating sensitive and motor function of each 4 terminal branches. | Within 30 minutes of block performance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance time during the brachial plexus block | the sum of: 1. the acquisition time of the sonographic image and 2. the time to perform block itself (from skin anesthesia to the end of LA injection) | Intraoperative (During block performance) | 
| Number of needle passes | The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass | Intraoperative (During block performance) | 
| Procedure pain during the brachial plexus block | Pain reported during procedure, rated acording to a visual rating scale from 0 to 10 points (0= no pain and 10= worst imaginable pain) | Intraoperative (During block performance) | 
| Incidence of surgical anesthesia | Incidence of surgeries performed without the supplemental use of local anesthetics infiltration, narcotics or general anesthesia | Thirty minutes after block performance | 
| Incidence of Adverse events | Incidence of adverse events related to brachial plexus block ((paresthesia, vascular puncture, hematoma, Horner syndrome, pneumothorax) | Intraoperative (During block performance) |