Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study

NCT ID: NCT02657291

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.

Detailed Description

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Infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the upper limb. Traditionally, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to the axillary artery. A recently introduced technique is the costoclavicular approach where the cords are viewed as relatively more superficial and clustered together compared to the traditional technique. Those meeting the inclusion criteria and will consent to participate in the study will be randomized to have either an infraclavicular block in the paracoracoid approach (Group 1) or an infraclavicular block in the costoclavicular approach (Group 2). All groups will have the same injectable volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). There will be 35 study patients for each group for a total of 70 patients.

Conditions

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Upper Limb Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Costoclavicular

Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Local anesthetic

Ultrasound

Intervention Type DEVICE

Ultrasound guided block

Paracoracoid

Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Local anesthetic

Ultrasound

Intervention Type DEVICE

Ultrasound guided block

Interventions

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Ropivacaine

Local anesthetic

Intervention Type DRUG

Ultrasound

Ultrasound guided block

Intervention Type DEVICE

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* Ambulatory elective surgery of the upper limb
* ASA (American Society of Anesthesiologists physical status classification system) 1-4
* Suitable for procedure to be carried out under infraclavicular block

Exclusion Criteria

* Inability to give informed consent, Allergy to local anesthetics, morphine or fentanyl
* Ongoing major medical or psychiatric problems
* Narcotic abuse
* Peripheral neuropathy or major neurological problems
* Scarring in area of blockade
* Inability to co-operate with post-operative evaluation
* Major coagulopathy
* Pregnancy and breast-feeding
* Women of childbearing age who are not taking adequate contraceptive precautions
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Shalini Dhir

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shalini Dhir

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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St. Joseph's Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.

Reference Type BACKGROUND
PMID: 25899958 (View on PubMed)

Bigeleisen P, Wilson M. A comparison of two techniques for ultrasound guided infraclavicular block. Br J Anaesth. 2006 Apr;96(4):502-7. doi: 10.1093/bja/ael024. Epub 2006 Feb 24.

Reference Type BACKGROUND
PMID: 16500953 (View on PubMed)

Mosaffa F, Gharaei B, Rafeeyan M, Gachkar L. Comparing vertical and coracoid approaches for infraclavicular block in orthopedic surgery of the forearm and hand. J Clin Anesth. 2012 May;24(3):196-200. doi: 10.1016/j.jclinane.2011.07.013. Epub 2012 Apr 5.

Reference Type BACKGROUND
PMID: 22484026 (View on PubMed)

Acar S, Gurkan Y, Solak M, Toker K. Coracoid versus lateral sagittal infraclavicular block. Acta Orthop Traumatol Turc. 2013;47(1):32-7. doi: 10.3944/aott.2013.2615.

Reference Type BACKGROUND
PMID: 23549315 (View on PubMed)

Other Identifiers

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LawsonHRI

Identifier Type: -

Identifier Source: org_study_id

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