NCT06499181

Multimodal Orthognathic Study Comparing Use of Exparel With Standard of Care.

Can Using Exparel Decrease the Post Operative Use of Narcotics in Maxillary Orthognathic Surgery?

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: United States Naval Medical Center, San Diego · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	The primary objective is to examine differences in post-operative opioid consumption between the two groups.
DRUG	Bupivacain	Control group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care.
DRUG	Epinephrin	Control group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care.

Timeline

• Start date: 2018-02-28
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2024-07-12
• Last updated: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study