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

Upper Limb Injury Clinical Trial

— CPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657291
• Other study ID #: LawsonHRI
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arm Injuries
• Upper Limb Injury

Intervention

Drug:
• Ropivacaine
Local anesthetic

Device:
• Ultrasound
Ultrasound guided block

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Acar S, Gürkan Y, Solak M, Toker K. Coracoid versus lateral sagittal infraclavicular block. Acta Orthop Traumatol Turc. 2013;47(1):32-7. — View Citation

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

Outcome

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