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

Primary Purpose

Upper Limb Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ropivacaine
Ultrasound
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Limb Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Costoclavicular

Paracoracoid

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2015
Last Updated
January 17, 2021
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02657291
Brief Title
Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
Acronym
CPI
Official Title
Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Costoclavicular
Arm Type
Experimental
Arm Description
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach
Arm Title
Paracoracoid
Arm Type
Active Comparator
Arm Description
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Local anesthetic
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound guided block
Primary Outcome Measure Information:
Title
Block onset time
Description
From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Procedure duration
Description
From the time the US probe touches the skin to the time the needle is removed
Time Frame
1 hour
Title
Quality of block
Time Frame
1 hour
Title
Patient satisfaction
Description
Satisfaction score (VAS ranging from 0 = completely dissatisfied to 10 = completely satisfied)
Time Frame
1 day
Title
Requirement for supplemental analgesia or anesthesia
Description
Quality of block will be assessed if adequate for surgery
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Dhir
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25899958
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.
Results Reference
background
PubMed Identifier
16500953
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.
Results Reference
background
PubMed Identifier
22484026
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.
Results Reference
background
PubMed Identifier
23549315
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.
Results Reference
background

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

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