Exparel Injection Effect on Postoperative Opioid Usage

Last updated: July 26, 2024
Sponsor: University of Missouri-Columbia
Overall Status: Active - Enrolling

Phase

1

Condition

Parathyroid Disease

Parathyroid Disorders

Hyperparathyroidism

Treatment

Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine

Bupivacaine Hydrochloride-EPINEPHrine

Lidocaine Epinephrine

Clinical Study ID

NCT04085913
2014881
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The question proposed by this study, is one of patient outcomes. Does intraoperative injection of Exparel decrease postoperative use of opioid pain medications in patients undergoing thyroid and parathyroid surgery? The trial seeks to assess the effect that Exparel has on postoperative pain control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over the age of 18 years Patients requiring parathyroid/thyroid surgerybased on the standard of care English as primary language

Exclusion

Exclusion Criteria:

  • Patients under the age of 18 years Patients with previous history of opioid abusePatients with a true allergy to any local anesthetic Patients with a true allergy toany opioid

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
Phase: 1
Study Start date:
September 30, 2019
Estimated Completion Date:
July 31, 2025

Study Description

Patients will be identified in clinic as good candidates for surgical intervention based on current standard of care. Once participants are consented, they will be randomly placed into one of three categories. The first category being patients undergoing surgery with local injection of lidocaine and epinephrine as is current practice. The second category of patients will undergo surgery with local injection of bupivacaine HCL and epinephrine preincision. The third group will undergo surgery with local injection of lidocaine and epinephrine preincision and Exparel postincision. As stated above, all patients will undergo surgery as planned, which will be standard of care, with the exception of the local anesthetic and timing of the injection. Postoperatively, patient's pain scores and opioid usage will be evaluated. Patients will be monitored by either using the patient's electronic medical record or by a pain journal that will be provided to the patients. The patients will record their pain using a scale of 1-10 with the FACES scale, as well as medication usage. Patients will return to their first postoperative appointment to further discuss their pain levels as well as medication usage. An ANOVA test will be used to determine if there is a significant difference in the amount of opioids taken postoperatively, in oral morphine equivalents, between these three groups. Opioid usage will then be compared between participants in different categories of local anesthetic to determine if there is an effect of postoperative opioid usage between different anesthetics.

Connect with a study center

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

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