Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

This study has been terminated.
(procedure no longer being done)
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00875862
First received: April 3, 2009
Last updated: April 21, 2011
Last verified: October 2009
  Purpose

Research study to determine if putting local anesthetic through a tiny tube next to the nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder procedure performed on the frozen shoulder. It will also help determine if patients have a higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their post-procedure pain control.


Condition Intervention Phase
Adhesive Capsulitis
Post-operative Pain
Procedure: Interscalene catheter with Ropivicaine or normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks: A Randomized, Triple-Masked, Placebo-Controlled Study

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Passive glenohumeral abduction, as evaluated using standard goniometry restricting scapular movement in a supine position. The difference in abduction the day following manipulation compared with the pre-manipulation value, expressed as a percentage. [ Time Frame: change from baseline: measured immediately prior to manipulation and the morning following the manipulation. ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. 0.2% Ropivicaine perinueral infusion
Patients will receive normal standard of care post-manipulation (single-injection brachial plexus nerve block, oral analgesics, and cold therapy). They will then be randomized to 0.2% Ropivicaine attached to the perineural catheter and an infusion will be initiated. The outcome measures will be assessed by study staff on the phone and at regular visits to the surgeon's office.
Procedure: Interscalene catheter with Ropivicaine or normal saline
Patients will be randomized to one of two groups: 0.2% Ropiviciane or normal saline in the infusion pump, following a shoulder manipulation for adhesive capsulitis. The patients will be followed by doctors and study staff to assess pain, range-of-motion and quality-of-life.
Placebo Comparator: 2. Normal Saline perineural infusion
Patients will receive normal standard of care post-manipulation (single-injection brachial plexus nerve block, oral analgesics, and cold therapy). They will then be randomized to normal saline attached to the perineural catheter and an infusion will be initiated. The outcome measures will be assessed by study staff on the phone and at regular visits to the surgeon's office.
Procedure: Interscalene catheter with Ropivicaine or normal saline
Patients will be randomized to one of two groups: 0.2% Ropiviciane or normal saline in the infusion pump, following a shoulder manipulation for adhesive capsulitis. The patients will be followed by doctors and study staff to assess pain, range-of-motion and quality-of-life.

Detailed Description:

Primary Specific Aim: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in increased shoulder abduction following treatment for adhesive capsulitis of the shoulder.

Hypothesis: Following shoulder manipulation under a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve blcok to usual and customary post-manipulation analgesia will result in a significantly greater shoulder abduction improvement the day following the manipulation.

Secondary Specific Aims: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in an increased quality-of-life and shoulder range-of-motion, as well as a decreased chronic pain following treatment for adhesive capsulitis of the shoulder.

Hypothesis 1: Following shoulder manipulation under a single-injection interscalene blcok for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and customary post-manipulation analgesia will result in a significantly increased quality-of-life improvement and shoulder range-of-motion compared wiht baseline values after three months.

Hypothesis 2: Following shoulder manipulation undera a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and costomary post-manipulation analgesia will result in a significantly decreased chronic pain compared with basedline falues after three months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing theraputic manipulation for adhesive capsulitis of the shoulder
  • age 18 years or older
  • accepting a single-injection nerve block for manipulation
  • understanding possible perineural infusion-related complications, study protocol, and catheter/pump care
  • having caretaker through the first night after manipulation
  • having an ASA physical status classification of 1-3

Exclusion Criteria:

  • Any contraindications for a CISB
  • any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
  • known allergy or other contraindication to the study medications
  • pregnancy
  • known hepatic or renal insufficiency/disease
  • peripheral neuropathy of the surgical extremity
  • morbid obesity
  • inability to communicate with the investigators and hospital staff
  • moderate-to-severe shoulder arthritis
  • immunocompromised status of any etiology
  • incarceration
  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: NCT00875862

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Ilfeld, M.D., M.S./ Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00875862     History of Changes
Other Study ID Numbers: Adhesive Capsulitis
Study First Received: April 3, 2009
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
UCSD
pain
quality-of-life
range-of-motion
interscalene catheter
nerve block
shoulder
Shoulder Manipulation

Additional relevant MeSH terms:
Pain, Postoperative
Bursitis
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014