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Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

NCT03844451 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-02-18

No results posted yet for this study

Summary

The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).

Conditions

  • Pain, Postoperative

Interventions

DRUG

Liposomal Bupivacaine

At the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block.

DRUG

Bupivacaine and Epinephrine

At the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Kristopher Day, MD · Dell Children's Medical Center of Central Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-17
Primary Completion
2019-09-01
Completion
2019-11-01
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 NCT03844451 on ClinicalTrials.gov