Exparel Injection Effect on Postoperative Opioid Usage

NCT04085913 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: 2014881
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid; Parathyroid Adenoma

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Current Practice

ACTIVE COMPARATOR

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

Drug: Lidocaine Epinephrine

Bupivicaine HCL

EXPERIMENTAL

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

Drug: Bupivacaine Hydrochloride-EPINEPHrine

Exparel Injection

EXPERIMENTAL

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

Drug: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine

Interventions

Lidocaine Epinephrine DRUG

Preincision injection, as is current practice

Current Practice

Bupivacaine Hydrochloride-EPINEPHrine DRUG

Preincision injection

Also known as: Exparel

Bupivicaine HCL

Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine DRUG

Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel

Also known as: Exparel

Exparel Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Thyroid Diseases; Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases

Study Officials

• Tabitha Galloway, MD

  University of Missouri Department of Otolaryngology-Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Otolaryngology

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: September 11, 2019
• Study Start: September 30, 2019
• Primary Completion: June 6, 2024
• Study Completion: July 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)