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Pain | Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:interscalene catheterinterscalene catheter

Procedure:interscalene blockinterscalene block

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

interscalene blockinterscalene block

interscalene catheterinterscalene catheter

Study Status

Unknown status

Start Date: June 2011

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: pain on post-operative day 1

Secondary Outcome: Pain post operative day 2 (POD2)

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of Wisconsin, Madison

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01385449

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