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

NCT06499181 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-07-19

No results posted yet for this study

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

Interventions

DRUG

Liposomal bupivacaine

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

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.

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.

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • Patrick T Morrell, DMD · United States Naval Medical Center, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2020-01-01
Completion
2020-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499181 on ClinicalTrials.gov