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Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01385449
Enrollment
73
Registered
2011-06-30
Start date
2011-06-30
Completion date
2016-02-29
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

nerve block, shoulder surgery, physical therapy

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.

Interventions

PROCEDUREinterscalene block

interscalene block

interscalene catheter

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain on post-operative day 124 hoursPain score on post-operative day 1(POD1) using numeric rating scale (NRS)

Secondary

MeasureTime frameDescription
Pain post operative day 2 (POD2)48 hoursNRS score on POD2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026