Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

Post-operative Pain Clinical Trial

Official title:

Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks: A Randomized, Triple-Masked, Placebo-Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00875862
• Other study ID #: Adhesive Capsulitis
• Status: Terminated
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Pain, Postoperative
• Post-operative Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		change from baseline: measured immediately prior to manipulation and the morning following the manipulation.