Clinical trial

Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery

Name
2014881
Description
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.
Trial arms
Trial start
2019-09-30
Estimated PCD
2024-07-01
Trial end
2024-07-01
Phase
Early phase I
Treatment
Lidocaine Epinephrine
Preincision injection, as is current practice
Arms:
Current Practice
Bupivacaine Hydrochloride-EPINEPHrine
Preincision injection
Arms:
Bupivicaine HCL
Other names:
Exparel
Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine
Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel
Arms:
Exparel Injection
Other names:
Exparel
Size
100
Primary endpoint
Incidence of opioid use when given Exparel intraoperatively
After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-04-28

1 organization

3 products

2 indications

Indication
Thyroid