Prospective Evaluation of Interscalene Nerve Catheters vs... | NCT01385449

Studies
Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

NCT01385449

Sponsor

University of Wisconsin, Madison

Status

Terminated

Last Update Posted

Feb 18, 2019Actual

Enrollment

73Actual

Phase

Not Applicable

Conditions

Pain

Interventions

interscalene catheter
interscalene 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 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was halted prematurely due to low enrollment and anticipation of future barriers to enrollment.

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 29, 2011

First Posted Date

Jun 30, 2011Estimated

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 14, 2019

Last Update Posted Date

Feb 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.

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

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
interscalene block	Experimental	interscalene block	Procedure: interscalene block
interscalene catheter	Experimental	interscalene catheter	Procedure: interscalene catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
interscalene catheter	Procedure	interscalene catheter	interscalene catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain on post-operative day 1	Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pain post operative day 2 (POD2)	NRS score on POD2	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status 1-3
18-79 years of age, inclusive
body mass index of < 36 kg/m2.
The ability to understand local anesthetic related complications and care of a CPNB
Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
The ability to communicate with the practitioner managing the catheter.
Residence within 2 hours of University of Wisconsin Hospital and Clinics

Exclusion Criteria:

Any contraindication to a continuous interscalene catheter placement
Clinically significant pulmonary disease
Clinically significant cardiac disease
Allergy to ropivacaine
Peripheral or central nervous system disease
Current (or planned) anticoagulation therapy or disease
Local infection over area of catheter placement
Renal or hepatic failure
History of opioid dependence
Significant psychiatric disease
Pregnancy or lactation (Subjects will be asked if it is possible they could be pregnant. If a subject responds in the affirmative, a pregnancy test will be done.)
Seizure Disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
U of Wisconsin		Madison	Wisconsin	53705	United States
University of Wisconsin

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided