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Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

ENHANCED RECOVERY AFTER ORTHOGNATHIC SURGERY USING LIPOSOMAL BUPIVACAINE: A RANDOMIZED CONTROL TRIAL

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844451
Enrollment
75
Registered
2019-02-18
Start date
2019-05-17
Completion date
2019-11-01
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Exparel, liposomal bupivacaine, postoperative, pain control

Brief 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).

Detailed description

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). The total study population size (N = 60) was determined by power analysis using a free online calculator for continuous variable comparison with two-sided equality. The hypotheses for this study is that a trigeminal nerve block LB-ERAS will confer better pain control to patients undergoing OGS compared to conventional bupivacaine and no ERAS protocol. We speculate that hospital stay, pain scores, duration to first postoperative oral intake, opioid pain medication requirements, and ORAE's will all be less in the TG than the CG. We postulate that the volume of oral nutrition tolerated in the first 48-hours postoperatively will be greater in the TG than the CG. Liposomal bupivacaine will be injected after a minimum of 20 minutes have passed since the pre-operative nerve block was administered. The patients' subjective pain experienced will be quantified by a traditional 10-point visual analogue score (VAS) in the post-anesthesia care unit (PACU), at time of admission to the post-operative recovery room, throughout the inpatient recovery period, and at time of discharge. The time to tolerance of first oral intake will be measured in hours. The amount of first-48-hour oral intake will be measured in milliliters (mL). We believe that a LB-ERAS protocol will result in lower necessary doses of opioid pain medications. This will be measured as first 48-hour total mg/kg dosage of opioid pain medication converted to oxycodone-equivalents by standard conversion ratios. The incidence of ORAE's will be tallied by the number of necessary prn doses of symptomatic management anti-pyretic and anti-nausea medications. We expect this to be lower in the TG. The degree of respiratory suppression will be measured by first 48-hour respiratory rate between CG and TG patients, which we expect to be lower in the CG relative to higher opioid pain medication totals.

Interventions

DRUGLiposomal Bupivacaine

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

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

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* All patients undergoing orthognathic surgery at Dell Children's Medical Center will be intended for inclusion in the study.

Exclusion criteria

* Only those patients with insufficient data in their medical records or contraindications to the administration of liposomal bupivacaine (hepatic disease or allergy to amide local anesthetics) will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Duration of hospitalization status post jaw surgeryUntil discharge from hospital, an average of 3 daysThe amount of time spent in the hospital after the surgery

Secondary

MeasureTime frameDescription
Total morphine-equivalentsFirst 48 hours after surgeryAmount of morphine-equivalents consumed by patient
Pain ScoresUntil discharge from hospital, an average of 3 daysOn a 1-10 visual analogue scale, measured per nursing with vital signs
Oral intakeFirst 48 hours after surgeryOral intake measured in cc

Countries

United States

Contacts

Primary ContactKristopher Day, MD
kristophermday@gmail.com3196019283
Backup ContactRaymond Harshbarger, MD
RJHarshbarger@ascension.org(512) 324-0644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026