Local Anesthesia for Facial Fractures

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06429501
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine/Epinephrine — DRUG
    injection
  • Saline — DRUG
    injection

Study Details

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.

Key Dates

Start date
Apr 2, 2024
Status verified
Feb 2026
Primary completion
Feb 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63110
Sara Kukuljan
[email protected]
314-362-7563
Amrita Hari-Raj, MD
[email protected]
314-518-6410

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By research site
Washington University· St Louis, MO

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