Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Not Applicable

• Conditions: Frozen Shoulder
• Interventions: Procedure: Interscalene block with nerve catheter

• Registration Number: NCT01606332
• Lead Sponsor: OAD Orthopaedics

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-25
• Study Start: 2012-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interscalene block with nerve catheter	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

Primary Outcome Measures

Name	Time	Method
Improvement in shoulder function as demonstrated by increased range of motion	10 days, 4, 8, 16 weeks and 6 months	The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.

Secondary Outcome Measures

Name	Time	Method
Decrease in shoulder pain	10 days, 4, 8, 16 weeks and 6 months	The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.

Trial Locations

Locations (1)

OAD Orthopaedics; 🇺🇸 Warrenville, Illinois, United States