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Exparel for Post-Surgery Pain Management in Thyroid Conditions
Phase < 1
Waitlist Available
Led By Tabitha Galloway, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients requiring parathyroid/thyroid surgery based on the standard of care
Be older than 18 years old
Must not have
Patients under the age of 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing whether a medication called Exparel can decrease the amount of opioids needed for pain control after surgery.
Who is the study for?
This trial is for English-speaking adults over 18 who need thyroid or parathyroid surgery. It's not open to those under 18, with a history of opioid abuse, or allergies to local anesthetics or opioids.
What is being tested?
The study tests if Exparel, when injected during surgery, reduces the need for opioid painkillers after thyroid and parathyroid surgeries. It aims to improve postoperative pain management.
What are the potential side effects?
Possible side effects may include reactions at the injection site such as swelling and redness, nerve damage symptoms like numbness or tingling, allergic reactions, and low blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for my parathyroid or thyroid as recommended by my doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of opioid use when given Exparel intraoperatively
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Exparel InjectionExperimental Treatment1 Intervention
Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision
Group II: Bupivicaine HCLExperimental Treatment1 Intervention
Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision.
Group III: Current PracticeActive Control1 Intervention
Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice.
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,394 Total Patients Enrolled
Tabitha Galloway, MDPrincipal InvestigatorUniversity of Missouri Department of Otolaryngology-Head and Neck Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I need surgery for my parathyroid or thyroid as recommended by my doctor.I am over 18 years old.You have a history of misusing opioid medications.You have a real allergy to any local numbing medicine.You have a confirmed allergy to any opioid.
Research Study Groups:
This trial has the following groups:- Group 1: Exparel Injection
- Group 2: Bupivicaine HCL
- Group 3: Current Practice
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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