NCT02117778

Brief Summary

This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. The investigators hypothesize that all three groups would have similar pain control; the supraclavicular and suprascapular groups may have better lung function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2014

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

First Submitted

Initial submission to the registry

January 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

January 24, 2014

Last Update Submit

February 2, 2017

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Lung function

    Vital Capacity, Spirometry

    Post-Operative Day 1

Secondary Outcomes (3)

  • Pain

    Post Operative Day 1

  • Opioid Consumption

    Post Operative Day 1

  • Sensory and Motor Function

    Post Operative Day 1

Study Arms (3)

Interscalene

ACTIVE COMPARATOR

Continuous Interscalene Nerve Block

Procedure: Continuous Nerve Block

Supraclavicular

ACTIVE COMPARATOR

Continuous Supraclavicular Nerve Block

Procedure: Continuous Nerve Block

Suprascapular

ACTIVE COMPARATOR

Continuous Suprascapular Nerve Block

Procedure: Continuous Nerve Block

Interventions

Continuous Nerve BlockPROCEDURE
InterscaleneSupraclavicularSuprascapular

Eligibility Criteria

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

You may qualify if:

  • Unilateral total shoulder arthroplasty
  • ASA physical status I-III
  • \>18 years old
  • Non-pregnant (or lactating)
  • Consent to participate in the study

You may not qualify if:

  • Refusal to participate
  • \< 18 years old
  • Chronic opioid use
  • Localized infection
  • Pregnancy or lactating
  • Pre-existing coagulopathy
  • Allergy to ultrasound gel or local anesthetics
  • Diaphragmatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • David Auyong, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

April 21, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

US(1)