Single Versus Double Injection Costoclavicular Block

NCT ID: NCT03595514

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2018-12-31

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.

Conditions

Upper Extremity Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Single injection

Intervention Type: 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

lidocaine, bupivacaine, epinephrine, dexamethasone

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Double injection

Intervention Type: 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.

lidocaine, bupivacaine, epinephrine, dexamethasone

Intervention Type: DRUG

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

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 Type: 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.

Intervention Type: OTHER

lidocaine, bupivacaine, epinephrine, dexamethasone

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

De Tran

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

De Q Tran, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

De Q Tran, MD, FRCPC

Role: CONTACT

de_tran@hotmail.com

5149341934 ext. 43261

Facility Contacts

De QH Tran, MD, FRCPC

Role: primary

de_tran@hotmail.com

(514)934-1934 ext. 43261

Roderick J Finlayson, MD, FRCPC

Role: backup

(514)934-1934 ext. 43261

References

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.

Reference Type: DERIVED

PMID: 31941792 (View on PubMed)

Other Identifiers

MUHC 2019-4673

Identifier Type: -

Identifier Source: org_study_id