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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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. Once the patient leaves the OR, the rest of the providers will be blinded to which arm the patient has been randomized. The identity will be linked to a key that will be kept in a locked box inside a keypad entry office. All future pain assessors will be blinded to the arm of the study in which the patient is attached. The patients will be taught about the surveys during the original evaluation, the consent process, and again post-operatively. An email will be sent to the patients on the following morning for the first 7 days post-operatively.

Study Groups

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Experimental Group Exparel

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 Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

The primary objective is to examine differences in post-operative opioid consumption between the two groups.

Control Group Bupivacaine

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.

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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.

Epinephrin

Intervention Type DRUG

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.

Interventions

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Liposomal bupivacaine

The primary objective is to examine differences in post-operative opioid consumption between the two groups.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Exparel Marcaine, Sensorcaine Adrenalin Chloride, Epipen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes