Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Frozen Shoulder Clinical Trial

Official title:

Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01606332
• Other study ID #: AC001
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2012
• Last updated: June 10, 2013
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2013
• Source: OAD Orthopaedics
• Contact: Marjorie Delaney, APN
• Phone: 630-225-2554
• Email: marjorie.delaney[@]oadortho.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.

Description:

Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.

It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis

• Failed conservative treatment for a minimum of 4 months

• Patient had 3 sequential office visits with no clinical improvement

Exclusion Criteria:

• Adhesive capsulitis following a surgical procedure and/or fracture

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frozen Shoulder

Intervention

Procedure:
• Interscalene block with nerve catheter
Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours

Locations

Country	Name	City	State
United States	OAD Orthopaedics	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OAD Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in shoulder function as demonstrated by increased range of motion	The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.	10 days, 4, 8, 16 weeks and 6 months	No
Secondary	Decrease in shoulder pain	The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.	10 days, 4, 8, 16 weeks and 6 months	No