ThyroidEarly Phase 1NCT04085913
Exparel Injection Effect on Postoperative Opioid Usage
A Early Phase 1 study testing Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine and Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine in people with Thyroid and Parathyroid Adenoma, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Parathyroid Adenoma
- What is being tested?
- Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine and Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years Patients requiring parathyroid/thyroid surgery based on the standard of care English as primary language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery
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.
Read the 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
- Being tested
- Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine, Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
- Medical subject headings
- Thyroid Diseases, Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine EpinephrineDrug
Preincision injection, as is current practice
Bupivacaine Hydrochloride-EPINEPHrineDrug
Also called Exparel
Preincision injection
Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrineDrug
Also called Exparel
Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel
| Study group | Role | What they receive |
|---|---|---|
| Current Practice | Active comparator | Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice. Receives: Drug: Lidocaine Epinephrine |
| Bupivicaine HCL | Experimental | Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision. Receives: Drug: Bupivacaine Hydrochloride-EPINEPHrine |
| Exparel Injection | Experimental | Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision Receives: Drug: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start30 Sep 2019
- Primary completion6 Jun 2024
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tabitha L. Galloway, University of Missouri-Columbia
- Investigators
- Tabitha Galloway, MD, Principal investigator, University of Missouri Department of Otolaryngology-Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085913
- Sponsor's protocol ID
- 2014881
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2019
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan, because IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery
- ClinicalTrials.gov ID
- NCT04085913
- Acronym / sponsor ID
- 2014881
- Conditions
- Thyroid, Parathyroid Adenoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current Practice | Active comparator | Drug: Lidocaine EpinephrineThyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice. |
| Bupivicaine HCL | Experimental | Drug: Bupivacaine Hydrochloride-EPINEPHrineThyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision. |
| Exparel Injection | Experimental | Drug: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrineThyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 years Patients requiring parathyroid/thyroid surgery based on the standard of care English as primary language
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine EpinephrinePreincision injection, as is current practice | Drug | Current Practice |
| Bupivacaine Hydrochloride-EPINEPHrineAlso: ExparelPreincision injection | Drug | Bupivicaine HCL |
| Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrineAlso: ExparelPreincison injection of lidocaine and epinephrine and a postincision injection of Exparel | Drug | Exparel Injection |
Primary outcome
Incidence of opioid use when given Exparel intraoperatively
Time frame: After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.
Utilizing pain scale daily diary, we will evaluate the incidence of opioid usage in patients that have undergone thyroid/parathyroid surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No. There is no plan, because IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tabitha Galloway, MD principal investigator
University of Missouri Department of Otolaryngology-Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine and Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine in people with Thyroid and Parathyroid Adenoma, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of opioid use when given Exparel intraoperatively (time frame: After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.