Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

NCT00875862 | Terminated Phase 4

• 1 other identifier: Adhesive Capsulitis
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis; Post-operative Pain

Keywords

UCSD; pain; quality-of-life; range-of-motion; interscalene catheter; nerve block; shoulder; Shoulder Manipulation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

1. 0.2% Ropivicaine perinueral infusion

ACTIVE COMPARATOR

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

2. Normal Saline perineural infusion

PLACEBO COMPARATOR

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

Interventions

Interscalene catheter with Ropivicaine or normal saline 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.

1. 0.2% Ropivicaine perinueral infusion; 2. Normal Saline perineural infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

Related Publications (1)

• 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.

  PMID: 23423135 DERIVED

MeSH Terms

Conditions

Bursitis; Pain, Postoperative; Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Brian M Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

US (1)