Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery

February 2, 2017 updated by: Benaroya Research Institute

A Comparative Pulmonary Function Study of Continuous Supraclavicular, Suprascapular, and Interscalene Nerve Catheters After Total Shoulder Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interscalene
Continuous Interscalene Nerve Block
Procedure: Continuous Nerve Block
Active Comparator: Supraclavicular
Continuous Supraclavicular Nerve Block
Procedure: Continuous Nerve Block
Active Comparator: Suprascapular
Continuous Suprascapular Nerve Block
Procedure: Continuous Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: Post-Operative Day 1
Vital Capacity, Spirometry
Post-Operative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Post Operative Day 1
NRS Pain Scale
Post Operative Day 1
Opioid Consumption
Time Frame: Post Operative Day 1
Total opioid consumption x 24 hours
Post Operative Day 1
Sensory and Motor Function
Time Frame: Post Operative Day 1
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynometer
Post Operative Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Investigators

  • Principal Investigator: David Auyong, MD, Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRI IRB13086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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