Completed

Exparel for Reducing Narcotics After Maxillary Orthognathic Surgery

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Study Aim

This study aims to evaluate whether using Exparel can reduce the need for narcotics in adults after maxillary orthognathic surgery.

What is being tested

Liposomal bupivacaine

+ Bupivacain

+ Epinephrin

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

From 18 to 80 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: February 2018
See protocol details

Summary

Principal SponsorUnited States Naval Medical Center, San Diego
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 28, 2018

Actual date on which the first participant was enrolled.

This clinical trial explores the use of Exparel, a type of liposomal bupivacaine, in patients undergoing maxillary orthognathic surgery, a jaw surgery. The primary goal is to see if Exparel can reduce the need for opioids, which are strong painkillers that can have significant side effects and addiction potential, compared to the traditional use of bupivacaine alone. The study targets 100 individuals scheduled for this type of surgery and divides them into two groups: one receiving Exparel and the other receiving standard bupivacaine. This research is important because it could lead to better pain management options and improve recovery experiences, minimizing the risks associated with opioid use. Participants in the study will receive an injection of either 133 mg of Exparel or 50 mg of bupivacaine near the incision sites at the end of their surgery. All participants will have their anesthesia managed without opioids and will stay in the hospital for one night after the procedure for observation. Over the next week, participants will keep a daily diary to record their pain levels, quality of life factors like nausea and swelling, and any medications taken. After a week, they will return to the clinic to complete a questionnaire about their experience. This helps researchers determine how effective Exparel is in managing post-surgery pain and improving recovery.

Official TitleCan Using Exparel Decrease the Post Operative Use of Narcotics in Maxillary Orthognathic Surgery?
NCT06499181
Principal SponsorUnited States Naval Medical Center, San Diego
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
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

10 exclusion criteria prevent from participating
History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.

Contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone

Significant drug allergy history

Positive result from urine drug screen at pre-op visit

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The experimental arm will be injected with 133mg (10cc) of liposomal bupivacaine (Exparel) near to the incision site one time only at the completion of the procedure.

Group II

Active Comparator
The control arm will be injected with 10cc of 0.5% bupivacaine (50 mg) with 1:50,000 epinephrine near to the incision site one time only at the completion of the procedure per standard procedure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Naval Medical Center San Diego

San Diego, United StatesOpen Naval Medical Center San Diego in Google Maps
CompletedOne Study Center