Local Anesthesia for Facial Fractures

Last updated: May 20, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Saline

Bupivacaine/Epinephrine

Clinical Study ID

NCT06429501
202401085
  • Ages > 18
  • All Genders

Study Summary

The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults age 18 and over

  2. Isolated facial fracture to the mandible and/or midface undergoing surgical repair

  3. No allergy to local anesthetic

  4. Ability to read, write, and understand English

Exclusion

Exclusion Criteria:

  1. Patients under the age of 18

  2. Isolated nasal bone fracture

  3. Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bonyfractures outside of the face)

  4. Allergy to local anesthetic

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Saline
Phase: 2
Study Start date:
April 02, 2024
Estimated Completion Date:
July 01, 2025

Study Description

Effective pain management is critical to successful postoperative care and is known to decrease patient morbidity, incurred patient and hospital costs, and length of hospital stay. Pain and nausea after surgery for traumatic facial fractures can limit patients' early morbidity, oral intake, and ability to communicate.

The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative mandibular or midface fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence. The primary outcome measure is the amount of opioid that patients receive in PACU in morphine milligram equivalent (MMEs).

The purpose of the study is to define whether a perioperative bupivacaine nerve block results in a decrease in the amounts of opioids and antiemetics that patients receive in PACU after CMF trauma surgery.

Connect with a study center

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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