Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01385449
• Other study ID #: H-2010-0098
• Status: Terminated
• Phase: N/A
• Start date: June 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• interscalene catheter
interscalene catheter
• interscalene block
interscalene block

Locations

Country	Name	City	State
United States	U of Wisconsin	Madison	Wisconsin
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain on post-operative day 1	Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)	24 hours
Secondary	Pain post operative day 2 (POD2)	NRS score on POD2	48 hours