Single Versus Double Injection Costoclavicular Block

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT03595514
Collaborator
University of Chile (Other)
90
1
2
4.1
22.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Single injection
  • Other: Double injection
  • Drug: lidocaine, bupivacaine, epinephrine, dexamethasone
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RandomizedRandomized
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will not be allowed to see the ultrasound screen. Outcome assessors will not be present during the performance of the block.
Primary Purpose:
Other
Official Title:
A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block
Actual Study Start Date :
Jul 30, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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

Other: 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

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

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.

Other: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Onset time of brachial plexus blockade [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 Outcome Measures

  1. Performance time during the brachial plexus block [Intraoperative (During block performance)]

    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)

  2. Number of needle passes [Intraoperative (During block performance)]

    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

  3. Procedure pain during the brachial plexus block [Intraoperative (During block performance)]

    Pain reported during procedure, rated acording to a visual rating scale from 0 to 10 points (0= no pain and 10= worst imaginable pain)

  4. Incidence of surgical anesthesia [Thirty minutes after block performance]

    Incidence of surgeries performed without the supplemental use of local anesthetics infiltration, narcotics or general anesthesia

  5. Incidence of Adverse events [Intraoperative (During block performance)]

    Incidence of adverse events related to brachial plexus block ((paresthesia, vascular puncture, hematoma, Horner syndrome, pneumothorax)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montreal General Hospital Montreal Quebec Canada H3G-1A4

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: De Q Tran, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
De Tran, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT03595514
Other Study ID Numbers:
  • MUHC 2019-4673
First Posted:
Jul 23, 2018
Last Update Posted:
Aug 16, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2018