Status:
COMPLETED
Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction
Lead Sponsor:
United States Naval Medical Center, San Diego
Conditions:
Pain, Post-operative
Third Molar
Eligibility:
All Genders
18-44 years
Phase:
EARLY_PHASE1
Brief Summary
This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative p...
Detailed Description
The recruitment of patients is covered in another section. Once patients are recruited based on inclusion/exclusion criteria, they will be consented and randomized into one of the 2 arms. The pre and ...
Eligibility Criteria
Inclusion
- Male or female 18 years or older
- Scheduled for 3rd molar extraction (x4) with at least one mandibular 3rd molar impacted
- American Society of Anesthesiologists classification 1 or 2
- Able to provide consent, adhere to study schedule, complete study journal, and understand English
Exclusion
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids
- Contraindication to lidocaine, epinephrine, bupivacaine, or hydrocodone
- Significant drug allergy history
- Currently pregnant or nursing at time of study or within 1 month of drug administration
- Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches.
- Use of any of the following medication within 1 month of EXPAREL infiltration or if the medications are being given to control pain: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Nonadrenaline Reuptake Inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine.
- Current use of systemic glucocorticosteroids within 1 month of enrollment in the study
- No concurrent surgical procedures within 2 weeks before or after 3rd molar extractions
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06484439
Start Date
February 14 2018
End Date
December 1 2021
Last Update
July 10 2024
Active Locations (1)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134