Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

OAD Orthopaedics

Status: Unknown

Conditions: Frozen Shoulder

Treatments: Procedure: Interscalene block with nerve catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01606332

AC001

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Single in interscalene block

No Intervention group

Description:

Single indwelling interscalene block with ropivacaine 0.5% 10ml

Interscalene block with nerve catheter

Experimental group

Description:

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

Treatment:

Procedure: Interscalene block with nerve catheter