Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844451
• Other study ID #: 2018-09-0046
• Status: Recruiting
• Phase: Phase 4
• Start date: May 17, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2019
• Source: University of Texas at Austin
• Contact: Kristopher Day, MD
• Phone: 3196019283
• Email: kristophermday[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Liposomal Bupivacaine
At the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block.
• Bupivacaine and Epinephrine
At the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block.

Locations

Country	Name	City	State
United States	Dell Children's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

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