Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

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

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.

Study Overview

• Status: Terminated
• Conditions: Adhesive Capsulitis; Post-operative Pain
• Intervention / Treatment: Procedure: Interscalene catheter with Ropivicaine or normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (ESTIMATE): April 6, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: pain; nerve block; shoulder; UCSD; quality-of-life; range-of-motion; interscalene catheter; Shoulder Manipulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Pain, Postoperative; Bursitis
• Other Study ID Numbers: Adhesive Capsulitis