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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current Practice | Active Comparator | Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice. |
|
| Bupivicaine HCL | Experimental | Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision. |
|
| Exparel Injection | Experimental | Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Epinephrine | Drug | Preincision injection, as is current practice |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tabitha Galloway, MD | University of Missouri Department of Otolaryngology-Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
There is no plan, because IPD will not be shared with other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 4, 2026 | |
| Reset | Feb 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 4, 2026 | Feb 23, 2026 |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D010282 | Parathyroid Neoplasms |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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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.
| Bupivacaine Hydrochloride-EPINEPHrine |
| Drug |
Preincision injection |
|
|
| Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine | Drug | Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel |
|
|
| D006258 |
| Head and Neck Neoplasms |
| D010279 | Parathyroid Diseases |