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

Naval Medical Center

Status and phase: Completed; Early Phase 1

Conditions: Pain, Postoperative

Treatments: Drug: Liposomal bupivacaine; Drug: Epinephrin; Drug: Bupivacain

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06499181

NMCSD.2017.0067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

86 participants in 2 patient groups

Experimental Group Exparel

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine

Control Group Bupivacaine

Active Comparator group

Description:

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:

Drug: Bupivacain

Drug: Epinephrin