NCT04085913

Exparel Injection Effect on Postoperative Opioid Usage

Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Thyroid
• Parathyroid Adenoma

Interventions

Type	Name	Description
DRUG	Lidocaine Epinephrine	Preincision injection, as is current practice
DRUG	Bupivacaine Hydrochloride-EPINEPHrine	Preincision injection
DRUG	Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine	Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel

Timeline

• Start date: 2019-09-30
• Primary completion: 2024-06-06
• Completion: 2025-07-01
• First posted: 2019-09-11
• Last updated: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study