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Local Anesthesia for Pain Management in Facial Fractures (LAFF Trial)

Phase 2

Recruiting

Led By Amrita Hari_Raj, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Polytrauma (i.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)

Patients under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 month post surgery

Summary

This trial is looking at the effects of using bupivacaine nerve block during surgery on how quickly patients recover after surgery. Patients with facial fractures will either get bupivacaine or a

Who is the study for?

This trial is for patients with facial fractures requiring surgery. Participants must be eligible for the surgical procedure and able to receive injections prior to anesthesia emergence. Specific inclusion and exclusion criteria details are not provided.

What is being tested?

The study tests if bupivacaine nerve blocks help with pain management after surgery compared to saline (a placebo). Patients are randomly assigned to get either the real drug or a placebo without knowing which one they received.

What are the potential side effects?

Possible side effects of bupivacaine may include numbness, weakness, tingling sensations, dizziness, nausea, or an increased risk of infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery for a broken jaw or facial bones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was hospitalized for multiple bone fractures not including the face.

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I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 month post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 month post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bupivacaine injectionExperimental Treatment1 Intervention

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.

Group II: Saline injectionPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met