Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Procedure: interscalene catheter; Procedure: interscalene block

• Registration Number: NCT01385449
• Lead Sponsor: University of Wisconsin, Madison

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 available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interscalene catheter	interscalene catheter	interscalene catheter
interscalene block	interscalene block	interscalene block

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain post operative day 2 (POD2)	48 hours	NRS score on POD2

Trial Locations

Locations (2)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

U of Wisconsin; 🇺🇸 Madison, Wisconsin, United States