Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

NCT ID: NCT03844451

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-17
• Study Completion Date: 2019-11-01

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type: DRUG

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

Bupivacaine and Epinephrine

Intervention Type: DRUG

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

Nerve block only

The control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block.

Group Type: PLACEBO_COMPARATOR

Bupivacaine and Epinephrine

Intervention Type: DRUG

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

Interventions

Liposomal Bupivacaine

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

Intervention Type: DRUG

Bupivacaine and Epinephrine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Kristopher Day

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristopher Day, MD

Role: PRINCIPAL_INVESTIGATOR

Dell Children's Medical Center of Central Texas

Locations

Dell Children's Medical Center

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristopher Day, MD

Role: CONTACT

kristophermday@gmail.com

3196019283

Raymond Harshbarger, MD

Role: CONTACT

RJHarshbarger@ascension.org

(512) 324-0644

Facility Contacts

Kristopher Day, MD

Role: primary

kristophermday@gmail.com

319-601-9283

Other Identifiers

2018-09-0046

Identifier Type: -

Identifier Source: org_study_id