Using local anesthesia to manage pain in facial fracture surgery
The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial
PHASE2 · Washington University School of Medicine · NCT06429501
This study is testing if using a local pain medication during facial fracture surgery can help patients recover better and use less pain relief afterward.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06429501 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind randomized, placebo-controlled study that investigates the effects of perioperative bupivacaine nerve blocks on recovery metrics in patients undergoing surgery for facial fractures. Participants with isolated mandibular or midface fractures are randomly assigned to receive either bupivacaine or saline injections before waking from anesthesia. The primary goal is to assess the reduction in opioid and antiemetic use in the post-anesthesia care unit (PACU), which is crucial for improving patient outcomes and reducing hospital costs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with isolated facial fractures of the mandible or midface who are scheduled for surgical repair.
Not a fit: Patients with isolated nasal bone fractures or those with multiple bony fractures outside of the face may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for opioids and improve recovery experiences for patients undergoing facial fracture surgery.
How similar studies have performed: Previous studies have shown promising results with local anesthetic techniques in pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
St Louis, Missouri
- Washington University — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Amrita Hari_Raj, MD — Washington University School of Medicine
- Study coordinator: Amrita Hari-Raj, MD
- Email: amrita.hari-raj@wustl.edu
- Phone: 314-518-6410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain Management, otolaryngology, surgery, facial plastic, trauma