This trial is active, not recruiting.

Condition pain
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
interscalene block
interscalene block
interscalene block
interscalene catheter
interscalene catheter
interscalene catheter

Primary Outcomes

pain on post-operative day 1
time frame: 24 hours

Secondary Outcomes

Pain post operative day 2 (POD2)
time frame: 48 hours

Eligibility Criteria

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

Additional Information

Official title Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.