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

Not Applicable

Completed

• Conditions: Upper Limb Injury
• Interventions: Drug: Ropivacaine; Device: Ultrasound

• Registration Number: NCT02657291
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Costoclavicular	Ropivacaine	Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach
Costoclavicular	Ultrasound	Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach
Paracoracoid	Ropivacaine	Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach
Paracoracoid	Ultrasound	Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Joseph's Hospital; 🇨🇦 London, Ontario, Canada