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Clinical Trials/NCT03595514
NCT03595514
Unknown
Not Applicable

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

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country90 target enrollmentJuly 30, 2018

Overview

Phase
Not Applicable
Intervention
Single injection
Conditions
Upper Extremity Injury
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
90
Locations
1
Primary Endpoint
Onset time of brachial plexus blockade
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 30, 2018
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

De Tran

Professor

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

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

Arms & 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

Intervention: Single injection

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

Intervention: lidocaine, bupivacaine, epinephrine, dexamethasone

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.

Intervention: Double injection

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.

Intervention: lidocaine, bupivacaine, epinephrine, dexamethasone

Outcomes

Primary Outcomes

Onset time of brachial plexus blockade

Time Frame: Within 30 minutes of block performance

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.

Secondary Outcomes

  • Performance time during the brachial plexus block(Intraoperative (During block performance))
  • Procedure pain during the brachial plexus block(Intraoperative (During block performance))
  • Incidence of surgical anesthesia(Thirty minutes after block performance)
  • Number of needle passes(Intraoperative (During block performance))
  • Incidence of Adverse events(Intraoperative (During block performance))

Study Sites (1)

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