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

NCT06499181 | Completed Early Phase 1 FDA Drug

• 1 other identifier: NMCSD.2017.0067
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures.

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

  Daily up to seven days post operative procedure.

Secondary Outcomes (5)

• Post-operative nausea and vomiting

  Daily up to seven days post operative procedure.

• Post-operative sleeping quality.

  Daily up to seven days post operative procedure.

• Post operative quality of life.

  Daily up to seven days post operative procedure.

• Post operative oral function.

  Day of surgery and at seventh day post operative procedure.

• Post operative swelling.

  Day of surgery and on post operative procedure day seven.

Study Arms (2)

Experimental Group Exparel

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.

Drug: Liposomal bupivacaine

Control Group Bupivacaine

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.

Drug: Bupivacain; Drug: Epinephrin

Interventions

Liposomal bupivacaine DRUG

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

Also known as: Exparel

Experimental Group Exparel

Bupivacain 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.

Also known as: Marcaine, Sensorcaine

Control Group Bupivacaine

Epinephrin 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.

Also known as: Adrenalin Chloride, Epipen

Control Group Bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Currently pregnant or nursing at time of study or within 1 month of drug administration
• Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches
• 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.
• Current use of systemic glucocorticosteroids within 1 month of enrollment in the study.
• No concurrent procedures with 2 weeks before or after orthognathic procedure
• No more than 1 previous surgery for similar condition or diagnosis.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Patrick T Morrell, DMD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 12, 2024
• Study Start: February 28, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)