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

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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Injury
• Intervention / Treatment: Drug: Ropivacaine; Device: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Costoclavicular; Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach	Drug: Ropivacaine; Local anesthetic; Other Names: Naropin; Device: Ultrasound; Ultrasound guided block
Active Comparator: Paracoracoid; Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach	Drug: Ropivacaine; Local anesthetic; Other Names: Naropin; Device: Ultrasound; Ultrasound guided block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block onset time	From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration	From the time the US probe touches the skin to the time the needle is removed	1 hour
Quality of block		1 hour
Patient satisfaction	Satisfaction score (VAS ranging from 0 = completely dissatisfied to 10 = completely satisfied)	1 day
Requirement for supplemental analgesia or anesthesia	Quality of block will be assessed if adequate for surgery	1 day

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Shalini Dhir, Western University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: LawsonHRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided