Clinical trial NCT02657291: Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
Official title: Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Injury
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Block onset time
timeFrame: 1 hour
Secondary outcomes:
measure: Procedure duration
timeFrame: 1 hour
measure: Quality of block
timeFrame: 1 hour
measure: Patient satisfaction
timeFrame: 1 day
measure: Requirement for supplemental analgesia or anesthesia
timeFrame: 1 day
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: Western University
name: Shalini Dhir
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.