Single Versus Double Injection Costoclavicular Block

NCT03595514 | Unknown

• 1 other identifier: MUHC 2019-4673
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Performance time during the brachial plexus block

  Intraoperative (During block performance)

• Number of needle passes

  Intraoperative (During block performance)

• Procedure pain during the brachial plexus block

  Intraoperative (During block performance)

• Incidence of surgical anesthesia

  Thirty minutes after block performance

• Incidence of Adverse events

  Intraoperative (During block performance)

Study Arms (2)

Single Injection

ACTIVE COMPARATOR

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; Drug: lidocaine, bupivacaine, epinephrine, dexamethasone

Double Injection

EXPERIMENTAL

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; Drug: lidocaine, bupivacaine, epinephrine, dexamethasone

Interventions

Single injection OTHER

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

Single Injection

Double injection OTHER

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.

Double Injection

lidocaine, bupivacaine, epinephrine, dexamethasone DRUG

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

Double Injection; Single Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• American Society of Anesthesiologists classification 1-3
• body mass index between 18 and 30

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• University of Chile: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G-1A4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 31941792 DERIVED

MeSH Terms

Conditions

Arm Injuries

Interventions

Injections; Lidocaine; Bupivacaine; Epinephrine; Dexamethasone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• De Q Tran, MD, FRCPC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

De Q Tran, MD, FRCPC

CONTACT

5149341934; de_tran@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be allowed to see the ultrasound screen. Outcome assessors will not be present during the performance of the block.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 23, 2018
• Study Start: July 30, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)