Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Study Overview
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Brief Summary
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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
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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

Official Title
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Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Conditions
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Frozen Shoulder

Intervention / Treatment
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* Procedure: Interscalene block with nerve catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Single in interscalene block<br>Single indwelling interscalene block with ropivacaine 0.5% 10ml | |
| Experimental: Interscalene block with nerve catheter<br>Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours | Procedure: Interscalene block with nerve catheter<br>* Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |