NCT03844451

Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-17
• Primary completion: 2019-09-01
• Completion: 2019-11-01
• First posted: 2019-02-18
• Last updated: 2019-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study