Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

NCT03844451 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2018-09-0046
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Postoperative

Keywords

Exparel, liposomal bupivacaine, postoperative, pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total morphine-equivalents

  First 48 hours after surgery

• Pain Scores

  Until discharge from hospital, an average of 3 days

• Oral intake

  First 48 hours after surgery

Study Arms (2)

Liposomal bupivicaine with nerve block

EXPERIMENTAL

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; Drug: Bupivacaine and Epinephrine

Nerve block only

PLACEBO COMPARATOR

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

Drug: Bupivacaine and Epinephrine

Interventions

Liposomal Bupivacaine DRUG

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

Liposomal bupivicaine with nerve block

Bupivacaine and Epinephrine DRUG

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

Liposomal bupivicaine with nerve block; Nerve block only

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kristopher Day, MD

  Dell Children's Medical Center of Central Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristopher Day, MD

CONTACT

3196019283; kristophermday@gmail.com

Raymond Harshbarger, MD

CONTACT

(512) 324-0644; RJHarshbarger@ascension.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 18, 2019
• Study Start: May 17, 2019
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

US (1)