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Experimental Group Exparel for Postoperative Pain

Phase < 1
Waitlist Available
Led By Patrick T Morrell, DMD
Research Sponsored by United States Naval Medical Center, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery and on post operative procedure day seven.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Postoperative Pain
  • Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily up to seven days post operative procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily up to seven days post operative procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures.
Secondary study objectives
Post operative oral function.
Post operative quality of life.
Post operative swelling.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group ExparelExperimental Treatment1 Intervention
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: Control Group BupivacaineActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor
108 Previous Clinical Trials
23,054 Total Patients Enrolled
Patrick T Morrell, DMDPrincipal InvestigatorUnited States Naval Medical Center, San Diego
1 Previous Clinical Trials
80 Total Patients Enrolled
~11 spots leftby Nov 2025
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