Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

NCT ID: NCT01385449

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-02-29

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.

Conditions

Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interscalene block

interscalene block

Group Type: EXPERIMENTAL

interscalene block

Intervention Type: PROCEDURE

interscalene block

interscalene catheter

interscalene catheter

Group Type: EXPERIMENTAL

interscalene catheter

Intervention Type: PROCEDURE

interscalene catheter

Interventions

interscalene catheter

interscalene catheter

Intervention Type: PROCEDURE

interscalene block

interscalene block

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

U of Wisconsin

Madison, Wisconsin, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2010-0098

Identifier Type: -

Identifier Source: org_study_id