Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

February 14, 2019 updated by: University of Wisconsin, Madison

Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin
      • Madison, Wisconsin, United States, 53705
        • U of Wisconsin

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 to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interscalene block
Procedure: interscalene block
interscalene block
Experimental: interscalene catheter
Procedure: interscalene catheter
interscalene catheter

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

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

June 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 29, 2011

First Posted (Estimate)

June 30, 2011

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-2010-0098

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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