Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by OAD Orthopaedics
Sponsor:
Information provided by (Responsible Party):
OAD Orthopaedics
ClinicalTrials.gov Identifier:
NCT01606332
First received: May 23, 2012
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Frozen Shoulder
Procedure: Interscalene block with nerve catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

Resource links provided by NLM:


Further study details as provided by OAD Orthopaedics:

Primary Outcome Measures:
  • Improvement in shoulder function as demonstrated by increased range of motion [ Time Frame: 10 days, 4, 8, 16 weeks and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 days, 4, 8, 16 weeks and 6 months ] [ Designated as safety issue: No ]
    The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Single in interscalene block
Single indwelling interscalene block with ropivacaine 0.5% 10ml
Experimental: 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
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606332

Contacts
Contact: Marjorie Delaney, APN 630-225-2554 marjorie.delaney@oadortho.com

Locations
United States, Illinois
OAD Orthopaedics Recruiting
Warrenville, Illinois, United States, 60555
Contact: Marjorie L Delaney, APN    630-225-2554    marjorie.delaney@oadortho.com   
Sponsors and Collaborators
OAD Orthopaedics
Investigators
Principal Investigator: Aaron A Bare, MD OAD Orthopaedics
  More Information

No publications provided

Responsible Party: OAD Orthopaedics
ClinicalTrials.gov Identifier: NCT01606332     History of Changes
Other Study ID Numbers: AC001
Study First Received: May 23, 2012
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014