Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

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University of California San Diego

Status and phase

Terminated
Phase 4

Conditions

Post-operative Pain
Adhesive Capsulitis

Treatments

Procedure: Interscalene catheter with Ropivicaine or normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00875862
Adhesive Capsulitis

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

4 participants in 2 patient groups, including a placebo group

1. 0.2% Ropivicaine perinueral infusion
Active Comparator group
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.
Treatment:
Procedure: Interscalene catheter with Ropivicaine or normal saline
2. Normal Saline perineural infusion
Placebo Comparator group
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.
Treatment:
Procedure: Interscalene catheter with Ropivicaine or normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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