WithdrawnPhase 4

Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

Stopped: Investigator Decision

United States0Started 2018-03-17

Plain-language summary

The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Surgical candidate for primary total shoulder replacement or reverse total shoulder replacement * Patient must be 18 years or older * Patient must be willing and able to sign IRB approved informed consent form, and must be able to understand and agree to follow study protocol. Exclusion Criteria: * Severe bronchopulmonary disease * Oxygen dependent * Existing nerve injury * BMI \> 40 * Coagulation disorders * Allergy to ropivicaine or bupivacaine * History of drug or alcohol abuse * Opioid use within 3 days prior to surgery * ASA physical status \> lll * Discharge plan to Skilled nursing facility * Pregnant women * Non-English speaking patients

What they're measuring

Opioid consumption

Timeframe: post-operative day 1

Trial details

NCT IDNCT03474510

SponsorTriHealth Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-01

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