Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

This study is currently recruiting participants.
Verified December 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
Melanie Donnelly, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01385449
First received: June 28, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Pain
Procedure: interscalene catheter
Procedure: interscalene block

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • pain on post-operative day 1 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)


Secondary Outcome Measures:
  • Pain post operative day 2 (POD2) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    NRS score on POD2


Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interscalene block
interscalene block
Procedure: interscalene block
interscalene block
Experimental: interscalene catheter
interscalene catheter
Procedure: interscalene catheter
interscalene catheter

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385449

Contacts
Contact: melanie j donnelly, mph,md 608-263-5034 mjdonnelly@wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: melanie j donnelly    608-263-5034      
U of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: melanie j donnelly, md,mph    608-263-5034    mdonnelly4@gmail.com   
Principal Investigator: melanie j donnelly, md, mph         
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Melanie Donnelly, MD, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01385449     History of Changes
Other Study ID Numbers: H-2010-0098
Study First Received: June 28, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
nerve block
shoulder surgery
physical therapy

ClinicalTrials.gov processed this record on April 17, 2014