Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: interscalene catheter
* Procedure: interscalene block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interscalene block<br>interscalene block | Procedure: interscalene block<br>* interscalene block<br>|
| Experimental: interscalene catheter<br>interscalene catheter | Procedure: interscalene catheter<br>* interscalene catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain on post-operative day 1 | 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) | NRS score on POD2 | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve block, shoulder surgery, physical therapy