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Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

Primary Purpose

Adhesive Capsulitis, Post-operative Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interscalene catheter with Ropivicaine or normal saline
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring UCSD, pain, quality-of-life, range-of-motion, interscalene catheter, nerve block, shoulder, Shoulder Manipulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1. 0.2% Ropivicaine perinueral infusion

2. Normal Saline perineural infusion

Arm Description

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.

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.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2009
Last Updated
July 23, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00875862
Brief Title
Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks
Official Title
Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks: A Randomized, Triple-Masked, Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
procedure no longer being done
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis, Post-operative Pain
Keywords
UCSD, pain, quality-of-life, range-of-motion, interscalene catheter, nerve block, shoulder, Shoulder Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. 0.2% Ropivicaine perinueral infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2. Normal Saline perineural infusion
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Interscalene catheter with Ropivicaine or normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Ilfeld, M.D., M.S.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23423135
Citation
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.
Results Reference
derived

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Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

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