Clinical trial NCT06499181: Multimodal Orthognathic Study Comparing Use of Exparel With Standard of Care.
Official title: Can Using Exparel Decrease the Post Operative Use of Narcotics in Maxillary Orthognathic Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Postoperative
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2024-07-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control arm will be injected with 10cc of 0.5% bupivacaine with 1:50,000 epinephrine. The study arm will be injected with 133mg (10cc) of liposomal bupivacaine.
Primary purpose: TREATMENT

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's quality of life, versus traditional bupivicaine alone.

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 quality of life versus traditional bupivicaine alone. A total of 100 patients who would ordinarily undergo maxillary orthognathic procedures will be randomized into 2 groups. One group will receive 133mg of Exparel (must limit volume of product due to spaces involved and other studies in oral surgery have used 133mg) at the completion of the procedure while the control group receives 50 mg of bupivicaine at the completion of the procedure as is typical standard of care. The injections will be made in similar regions near the incision lines. No other differences will be made between the groups. Perioperative anesthesia will consist of non-opioid techniques, and patients will be monitored post-operatively during a 1 night hospital admission. Patients will complete an anonymous daily diary for 7 days. The diary will consist of information regarding pain scores, quality of life (nausea, swelling, oral function, etc) and medicines taken.

At one week post op the participant will return to the clinic where they will fill out a final questionnaire discussing the previous week's experience regarding the topics of the questionnaires.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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.

Primary outcomes:
measure: Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures.
timeFrame: Daily up to seven days post operative procedure.
Secondary outcomes:
measure: Post-operative nausea and vomiting
timeFrame: Daily up to seven days post operative procedure.
measure: Post-operative sleeping quality.
timeFrame: Daily up to seven days post operative procedure.
measure: Post operative quality of life.
timeFrame: Daily up to seven days post operative procedure.
measure: Post operative oral function.
timeFrame: Day of surgery and at seventh day post operative procedure.
measure: Post operative swelling.
timeFrame: Day of surgery and on post operative procedure day seven.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Patrick T Morrell, DMD
role: PRINCIPAL_INVESTIGATOR
References: