Local Anesthesia for Facial Fractures

Phase 2

Recruiting

• Conditions: Pain Management
• Interventions: Drug: Bupivacaine/Epinephrine; Drug: Saline

• Registration Number: NCT06429501
• Lead Sponsor: Washington University School of Medicine

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.

Detailed 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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-04-02
• Study First Submitted: 2024-04-23
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine injection	Bupivacaine/Epinephrine	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.
Saline injection	Saline	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.

Primary Outcome Measures

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

Name	Time	Method
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.	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. fenta...

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States