NCT02677506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

3.5 years

First QC Date

January 12, 2016

Last Update Submit

December 10, 2017

Conditions

Cubital Tunnel SyndromeBiceps Tendon Rupture

Keywords

elbow

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 minutes

Secondary Outcomes (1)

  • Readiness for surgery

    60 minutes

Study Arms (2)

Supraclavicular

EXPERIMENTAL

Supraclavicular brachial plexus block will be done.

Procedure: Supraclavicular

Infraclavicular

ACTIVE COMPARATOR

Infraclavicular brachial plexus block block will be done.

Procedure: Infraclavicular

Interventions

SupraclavicularPROCEDURE

Brachial plexus block with supraclavicular approach

Supraclavicular
InfraclavicularPROCEDURE

Brachial plexus block with infraclavicular approach

Infraclavicular

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Narcotic dependent
  • Severe systemic illness
  • Refusal of block
  • localized infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Shalini Dhir, FRCPC

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

January 12, 2016

First Posted

February 9, 2016

Study Start

January 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)