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Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385449
First Posted: June 30, 2011
Last Update Posted: October 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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: None (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 ]
    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 ]
    NRS score on POD2


Enrollment: 73
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385449


Locations
United States, Wisconsin
U of Wisconsin
Madison, Wisconsin, United States, 53705
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01385449     History of Changes
Other Study ID Numbers: H-2010-0098
First Submitted: June 28, 2011
First Posted: June 30, 2011
Last Update Posted: October 8, 2015
Last Verified: October 2015

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