Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:15 - 25
Updated:2/20/2019
Start Date:May 17, 2019
End Date:November 1, 2019
Contact:Kristopher Day, MD
Email:kristophermday@gmail.com
Phone:3196019283

Use our guide to learn which trials are right for you!

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

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 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.

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.
We found this trial at
1
site
Austin, Texas 78723
Phone: 319-601-9283
?
mi
from
Austin, TX
Click here to add this to my saved trials