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NCT Number: NCT06429501

Local Anesthesia for Facial Fractures

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18 and over
  • Isolated facial fracture to the mandible and/or midface undergoing surgical repair
  • No allergy to local anesthetic
  • Ability to read, write, and understand English

Exclusion criteria

  • Patients under the age of 18
  • Isolated nasal bone fracture
  • Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)
  • Allergy to local anesthetic

Treatment and study plan

Bupivacaine/Epinephrine

Drug

injection

Saline

Drug

injection

Primary outcomes

  1. Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs).

    Time frame: day 1 or the day of surgery

    To evaluate the impact of a perioperative bupivacaine nerve block on PACU opioid use in patients undergoing operative fixation of facial fractures compared to placebo nerve block assessment of the amount of opioids that patients receive in PACU in morphine milligram equivalents (MMEs) will be calculated.

Secondary outcomes

  1. Impact of a perioperative bupivacaine nerve block on antiemetic use as assessed by the numbers who receive opioids and antiemetics, amount of antiemetics, pain score, frequency of emesis, and time until discharge.

    Time frame: within 1 month post surgery

    To evaluate the impact of a perioperative bupivacaine nerve block on PACU antiemetic use in patients undergoing operative fixation of facial fractures compared to placebo nerve block. Additional variables that will be collected perioperatively include the medications used for induction/maintenance of anesthesia as well as intraoperative analgesia (I.e. fentanyl, hydromorphone, morphine, acetaminophen, ketorolac, etc.), operative time, estimated blood loss, and intraoperative complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Amrita Hari-Raj, MD

CONTACT

[email protected]

314-518-6410

Sara Kukuljan

CONTACT

[email protected]

314-362-7563

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial

Acronym: LAFF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 28, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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