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Exparel Injection Effect on Postoperative Opioid Usage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04085913
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tabitha L. Galloway, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Thyroid Parathyroid Adenoma Drug: Lidocaine Epinephrine Drug: Bupivacaine Hydrochloride-EPINEPHrine Drug: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (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.
Primary Purpose: Treatment
Official Title: Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Epinephrine

Arm Intervention/treatment
Active Comparator: Current Practice
Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice.
Drug: Lidocaine Epinephrine
Preincision injection, as is current practice

Experimental: Bupivicaine HCL
Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision.
Drug: Bupivacaine Hydrochloride-EPINEPHrine
Preincision injection
Other Name: Exparel

Experimental: Exparel Injection
Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision
Drug: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel
Other Name: Exparel




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085913


Contacts
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Contact: Rebecca Schneider, MS 573-882-2549 entresearch@health.missouri.edu
Contact: Collin Luebbering, BS 573-882-6301 cmluebbering@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Tabitha Galloway, MD University of Missouri Department of Otolaryngology-Head and Neck Surgery
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Responsible Party: Tabitha L. Galloway, Assistant Professor of Clinical Otolaryngology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04085913    
Other Study ID Numbers: 2014881
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan, because IPD will not be shared with other researchers.

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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
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Parathyroid Diseases
Lidocaine
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents