Status:

WITHDRAWN

Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

Lead Sponsor:

TriHealth Inc.

Conditions:

Pain, Postoperative

Shoulder Osteoarthritis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 n...

Detailed Description

Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of pain that may require opioid consumption for several days post-operatively. The side effects of opi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 17 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2019

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03474510

Start Date

March 17 2018

End Date

February 1 2019

Last Update

March 1 2021

Active Locations (1)

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1

Good Samarian Hospital

Cincinnati, Ohio, United States, 45220