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Exparel Injection Effect on Postoperative Opioid Usage

Primary Purpose

Thyroid, Parathyroid Adenoma

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Epinephrine
Bupivacaine Hydrochloride-EPINEPHrine
Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Current Practice

Bupivicaine HCL

Exparel Injection

Arm Description

Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice.

Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision.

Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision

Outcomes

Primary Outcome Measures

Incidence of opioid use when given Exparel intraoperatively
Utilizing pain scale daily diary, we will evaluate the incidence of opioid usage in patients that have undergone thyroid/parathyroid surgery

Secondary Outcome Measures

Full Information

First Posted
June 21, 2019
Last Updated
April 26, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04085913
Brief Title
Exparel Injection Effect on Postoperative Opioid Usage
Official Title
Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Parathyroid Adenoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Prospective, randomized research study to evaluate postoperative pain medication usage in patients scheduled and receiving thyroid/parathyroid surgery. Patients will be randomized into three different study groups, each receiving a different regiment of treatment.
Masking
Participant
Masking Description
During the consenting process, participants will be informed about the randomization aspect of the study. However, they will not be told what category/group they will be randomized into. To help with the randomization, the study team will enter the needed patient information into www.randomizer.org, which will categorize the patients into the desired groups.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Current Practice
Arm Type
Active Comparator
Arm Description
Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice.
Arm Title
Bupivicaine HCL
Arm Type
Experimental
Arm Description
Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision.
Arm Title
Exparel Injection
Arm Type
Experimental
Arm Description
Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision
Intervention Type
Drug
Intervention Name(s)
Lidocaine Epinephrine
Intervention Description
Preincision injection, as is current practice
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride-EPINEPHrine
Other Intervention Name(s)
Exparel
Intervention Description
Preincision injection
Intervention Type
Drug
Intervention Name(s)
Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
Other Intervention Name(s)
Exparel
Intervention Description
Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel
Primary Outcome Measure Information:
Title
Incidence of opioid use when given Exparel intraoperatively
Description
Utilizing pain scale daily diary, we will evaluate the incidence of opioid usage in patients that have undergone thyroid/parathyroid surgery
Time Frame
After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 years Patients requiring parathyroid/thyroid surgery based on the standard of care English as primary language Exclusion Criteria: Patients under the age of 18 years Patients with previous history of opioid abuse Patients with a true allergy to any local anesthetic Patients with a true allergy to any opioid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tabitha Galloway, MD
Organizational Affiliation
University of Missouri Department of Otolaryngology-Head and Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan, because IPD will not be shared with other researchers.

Learn more about this trial

Exparel Injection Effect on Postoperative Opioid Usage

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