Recruiting
Phase 2

Local Anesthesia

Sponsor:

Washington University School of Medicine

Code:

NCT06429501

Conditions

Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine/Epinephrine

Saline

Study Details

Brief 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.

Conditions

Pain Management

Study ID

NCT06429501

Start date

Apr 2, 2024

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 bony fractures outside of the face)
4. Allergy to local anesthetic

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bupivacaine injection

The surgeon will be provided with a 10 mL syringe, and he/she will be blinded to the contents of the syringe. The appropriate landmarks will be identified, and a 21, 25, or 27- gauge needle will be used to perform the nerve block with 0.25% bupivacaine.

placebo comparator: Saline injection

The placebo sham injection will be performed in an identical fashion as the nerve block with the exception of using 10 mL of 0.9% saline injection instead of bupivacaine.

Interventions

Bupivacaine/Epinephrine

injection

Saline

injection

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amrita Hari-Raj, MD

314-518-6410amrita.hari-raj@wustl.edu

Sara Kukuljan

314-362-7563kukuljas@wustl.edu

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sara Kukuljan

314-362-7563kukuljas@wustl.edu

Amrita Hari-Raj, MD

314-518-6410amrita.hari-raj@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • otolaryngology
  • surgery
  • facial plastic
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-02-25.