Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

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).

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Liposomal Bupivacaine; Drug: Bupivacaine and Epinephrine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kristopher Day, MD; Phone Number: 3196019283; Email: kristophermday@gmail.com
• Study Contact Backup: Name: Raymond Harshbarger, MD; Phone Number: (512) 324-0644; Email: RJHarshbarger@ascension.org

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Children's Medical Center
      • Contact: Kristopher Day, MD; Phone Number: 319-601-9283; Email: kristophermday@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Liposomal bupivicaine with nerve block; The treatment group will receive an intraoperative V2 trigeminal nerve block using liposomal bupivacaine in addition to a standard bupivacaine nerve block.	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.
PLACEBO_COMPARATOR: Nerve block only; The control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization status post jaw surgery	The amount of time spent in the hospital after the surgery	Until discharge from hospital, an average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine-equivalents	Amount of morphine-equivalents consumed by patient	First 48 hours after surgery
Pain Scores	On a 1-10 visual analogue scale, measured per nursing with vital signs	Until discharge from hospital, an average of 3 days
Oral intake	Oral intake measured in cc	First 48 hours after surgery

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Kristopher Day, MD, Dell Children's Medical Center of Central Texas

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 17, 2019
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (ACTUAL): February 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Exparel, liposomal bupivacaine, postoperative, pain control
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 2018-09-0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes