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Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery

Primary Purpose

Cubital Tunnel Syndrome, Biceps Tendon Rupture

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Supraclavicular

Infraclavicular

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring elbow

Eligibility Criteria

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

Inclusion Criteria:

Patients scheduled for ambulatory elbow surgery under block
ASA 1-3

Exclusion Criteria:

Narcotic dependent
Severe systemic illness
Refusal of block
localized infection

Sites / Locations

St. Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supraclavicular

Infraclavicular

Arm Description

Supraclavicular brachial plexus block will be done.

Infraclavicular brachial plexus block block will be done.

Outcomes

Primary Outcome Measures

Time to completion of block

A clock will be used to assess this outcome. Complete sensory block in all dermatomes will be tested with ice.

Secondary Outcome Measures

Readiness for surgery

A clock will be used to assess this outcome. Complete sensory and motor block at the time of incision will be considered readiness of surgery.

Full Information

NCT ID

NCT02677506

First Posted

January 12, 2016

Last Updated

December 10, 2017

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02677506

Brief Title

Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery

Official Title

A Randomized Comparison of Infraclavicular and Supraclavicular Brachial Plexus Blocks for Elbow Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.

Detailed Description

Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. Supraclavicular approach is considered to have a more rapid onset. However, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books). None of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. Therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.

6. Conditions and Keywords

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

Cubital Tunnel Syndrome, Biceps Tendon Rupture

Keywords

elbow

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supraclavicular

Arm Type

Experimental

Arm Description

Supraclavicular brachial plexus block will be done.

Arm Title

Infraclavicular

Arm Type

Active Comparator

Arm Description

Infraclavicular brachial plexus block block will be done.

Intervention Type

Procedure

Intervention Name(s)

Supraclavicular

Intervention Description

Brachial plexus block with supraclavicular approach

Intervention Type

Procedure

Intervention Name(s)

Infraclavicular

Intervention Description

Brachial plexus block with infraclavicular approach

Primary Outcome Measure Information:

Title

Time to completion of block

Description

A clock will be used to assess this outcome. Complete sensory block in all dermatomes will be tested with ice.

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Readiness for surgery

Description

A clock will be used to assess this outcome. Complete sensory and motor block at the time of incision will be considered readiness of surgery.

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled for ambulatory elbow surgery under block ASA 1-3 Exclusion Criteria: Narcotic dependent Severe systemic illness Refusal of block localized infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shalini Dhir, FRCPC

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

Learn more about this trial

Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery

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