Comparison of Pulmonary Function and Efficacy of Differen... | NCT02117778

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

NCT02117778

Sponsor

Benaroya Research Institute

Status

Completed

Last Update Posted

Feb 3, 2017Estimated

Enrollment

75Actual

Phase

Not Applicable

Conditions

Post-Operative Pain

Interventions

Continuous Nerve Block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jan 24, 2014

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2017

Last Update Posted Date

Feb 3, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Continuous Nerve Block	Procedure		Interscalene Supraclavicular Suprascapular

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pain	NRS Pain Scale	Post Operative Day 1
Opioid Consumption	Total opioid consumption x 24 hours	Post Operative Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Auyong, MD	Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Mason Medical Center		Seattle	Washington	98101	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided