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Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

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ClinicalTrials.gov Identifier: NCT01606332
Recruitment Status : Unknown
Verified June 2013 by OAD Orthopaedics.
Recruitment status was:  Recruiting
First Posted : May 25, 2012
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Procedure: Interscalene block with nerve catheter Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
Study Start Date : June 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Improvement in shoulder function as demonstrated by increased range of motion [ Time Frame: 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 :
  1. Decrease in shoulder pain [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: OAD Orthopaedics
ClinicalTrials.gov Identifier: NCT01606332     History of Changes
Other Study ID Numbers: AC001
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

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