Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks
This trial is active, not recruiting.
|Treatments||interscalene catheter, interscalene block|
|Sponsor||University of Wisconsin, Madison|
|Start date||June 2011|
|End date||July 2014|
|Trial size||73 participants|
|Trial identifier||NCT01385449, H-2010-0098|
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.
|Intervention model||parallel assignment|
pain on post-operative day 1
time frame: 24 hours
Pain post operative day 2 (POD2)
time frame: 48 hours
Male or female participants from 18 years up to 79 years old.
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
|Official title||Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting|
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