Status:
COMPLETED
Multimodal Orthognathic Study Comparing Use of Exparel With Standard of Care.
Lead Sponsor:
United States Naval Medical Center, San Diego
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
A prospective, randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient'...
Detailed Description
A prospective randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's...
Eligibility Criteria
Inclusion
- Male or female 18 years or older
- Scheduled for Maxillary Orthognathic Surgery
- American Society of Anesthesiologists classification 1,2,3
- Able to provide consent, adhere to study schedule, complete study journal
Exclusion
- 1 History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
- 2 Contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone
- 3 Significant drug allergy history
- 4 Positive result from urine drug screen at pre-op visit
- 5 Currently pregnant or nursing at time of study or within 1 month of drug administration
- 6 Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches
- 7 Use of any of the following medication within 1 month of liposomal bupivacaine 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.
- 8 Current use of systemic glucocorticosteroids within 1 month of enrollment in the study.
- 9 No concurrent procedures with 2 weeks before or after orthognathic procedure
- 10 No more than 1 previous surgery for similar condition or diagnosis.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06499181
Start Date
February 28 2018
End Date
January 1 2020
Last Update
July 19 2024
Active Locations (1)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134