Single Versus Double Injection Costoclavicular Block
Primary Purpose
Upper Extremity Injury
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Single injection
Double injection
lidocaine, bupivacaine, epinephrine, dexamethasone
Sponsored by
About this trial
This is an interventional other trial for Upper Extremity Injury
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
Sites / Locations
- Montreal General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single Injection
Double Injection
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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
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)
Incidence of surgical anesthesia
Incidence of surgeries performed without the supplemental use of local anesthetics infiltration, narcotics or general anesthesia
Incidence of Adverse events
Incidence of adverse events related to brachial plexus block ((paresthesia, vascular puncture, hematoma, Horner syndrome, pneumothorax)
Full Information
NCT ID
NCT03595514
First Posted
July 1, 2018
Last Updated
August 14, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
University of Chile
1. Study Identification
Unique Protocol Identification Number
NCT03595514
Brief Title
Single Versus Double Injection Costoclavicular Block
Official Title
A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Injection
Arm Type
Active Comparator
Arm Description
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
Arm Title
Double Injection
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Single injection
Intervention Description
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 Type
Other
Intervention Name(s)
Double injection
Intervention Description
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 Type
Drug
Intervention Name(s)
lidocaine, bupivacaine, epinephrine, dexamethasone
Intervention Description
lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone
Primary Outcome Measure Information:
Title
Onset time of brachial plexus blockade
Description
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.
Time Frame
Within 30 minutes of block performance
Secondary Outcome Measure Information:
Title
Performance time during the brachial plexus block
Description
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)
Time Frame
Intraoperative (During block performance)
Title
Number of needle passes
Description
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
Time Frame
Intraoperative (During block performance)
Title
Procedure pain during the brachial plexus block
Description
Pain reported during procedure, rated acording to a visual rating scale from 0 to 10 points (0= no pain and 10= worst imaginable pain)
Time Frame
Intraoperative (During block performance)
Title
Incidence of surgical anesthesia
Description
Incidence of surgeries performed without the supplemental use of local anesthetics infiltration, narcotics or general anesthesia
Time Frame
Thirty minutes after block performance
Title
Incidence of Adverse events
Description
Incidence of adverse events related to brachial plexus block ((paresthesia, vascular puncture, hematoma, Horner syndrome, pneumothorax)
Time Frame
Intraoperative (During block performance)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
De Q Tran, MD, FRCPC
Phone
5149341934
Ext
43261
Email
de_tran@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
De Q Tran, MD, FRCPC
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G-1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De QH Tran, MD, FRCPC
Phone
(514)934-1934
Ext
43261
Email
de_tran@hotmail.com
First Name & Middle Initial & Last Name & Degree
Roderick J Finlayson, MD, FRCPC
Phone
(514)934-1934
Ext
43261
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31941792
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.
Results Reference
derived
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Single Versus Double Injection Costoclavicular Block
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