Washington University
St Louis, Missouri, 63110, United States
Location status: Recruiting
Location contact
Amrita Hari-Raj, MD
CONTACT
Sara Kukuljan
CONTACT
NCT Number: NCT06429501
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
St Louis, Missouri, 63110, United States
Location status: Recruiting
Amrita Hari-Raj, MD
CONTACT
Sara Kukuljan
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
injection
injection
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.
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.
Contact information is provided by the study sponsor or research team.
Amrita Hari-Raj, MD
CONTACT
Sara Kukuljan
CONTACT
Washington University School of Medicine
Other
The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial
Acronym: LAFF
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.
Published trials that share one or more normalized conditions with this study.
NCT07480135
Acute Traumatic Wounds, Agnosia
Jette, Brussels Capital, Belgium
View Trial DetailsNCT06968546
Acute Pain, Agnosia
Nice, France
View Trial DetailsNCT05492903
Agnosia, Ergonomics
Portland, Oregon, United States
View Trial DetailsNCT07695987
Agnosia, Nervous System Diseases
Istanbul, Turkey (Türkiye)
View Trial Details