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Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Primary Purpose

Frozen Shoulder

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Interscalene block with nerve catheter

About this trial

This is an interventional treatment trial for Frozen Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

OAD OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Single in interscalene block

Interscalene block with nerve catheter

Arm Description

Single indwelling interscalene block with ropivacaine 0.5% 10ml

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decrease in shoulder pain

The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.

Full Information

NCT ID

NCT01606332

First Posted

May 23, 2012

Last Updated

June 10, 2013

Sponsor

OAD Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT01606332

Brief Title

Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Official Title

Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OAD Orthopaedics

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Frozen Shoulder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single in interscalene block

Arm Type

No Intervention

Arm Description

Single indwelling interscalene block with ropivacaine 0.5% 10ml

Arm Title

Interscalene block with nerve catheter

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Interscalene block with nerve catheter

Intervention Description

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 Measure Information:

Title

Improvement in shoulder function as demonstrated by increased range of motion

Description

The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.

Time Frame

10 days, 4, 8, 16 weeks and 6 months

Secondary Outcome Measure Information:

Title

Decrease in shoulder pain

Description

The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.

Time Frame

10 days, 4, 8, 16 weeks and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marjorie Delaney, APN

Phone

630-225-2554

marjorie.delaney@oadortho.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron A Bare, MD

Organizational Affiliation

OAD Orthopaedics

Official's Role

Principal Investigator

Facility Information:

Facility Name

OAD Orthopaedics

City

Warrenville

State/Province

Illinois

ZIP/Postal Code

60555

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marjorie L Delaney, APN

Phone

630-225-2554

marjorie.delaney@oadortho.com

12. IPD Sharing Statement

Learn more about this trial

Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

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