Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

NCT ID: NCT00875862

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

Brief 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.

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.

Conditions

Adhesive Capsulitis; Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Interscalene catheter with Ropivicaine or normal saline

Intervention Type: PROCEDURE

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.

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.

Group Type: PLACEBO_COMPARATOR

Interscalene catheter with Ropivicaine or normal saline

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Brian M. Ilfeld, MD, MS

Professor of Anesthesiology, In Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian M Ilfeld, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Medical Center

San Diego, California, United States

Countries

United States

References

Malhotra N, Madison SJ, Ward SR, Mariano ER, Loland VJ, Ilfeld BM. Continuous interscalene nerve block following adhesive capsulitis manipulation. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):171-2. doi: 10.1097/AAP.0b013e318283475b. No abstract available.

Reference Type: DERIVED

PMID: 23423135 (View on PubMed)

Other Identifiers

Adhesive Capsulitis

Identifier Type: -

Identifier Source: org_study_id