Pain ManagementPhase 2LAFFNCT06429501
Local Anesthesia for Facial Fractures
A Phase 2 study testing Bupivacaine/Epinephrine and Saline in people with Pain Management, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Bupivacaine/Epinephrine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 and over
- Isolated facial fracture to the mandible and/or midface undergoing surgical repair
- No allergy to local anesthetic
- Ability to read, write, and understand English
Who cannot join
- Patients under the age of 18
- Isolated nasal bone fracture
- Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)
- Allergy to local anesthetic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University
St Louis, Missouri, 63110
Sara Kukuljan, 314-362-7563, kukuljas@wustl.edu
Amrita Hari-Raj, MD, 314-518-6410, amrita.hari-raj@wustl.edu
About this study
Official title: The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial
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.
Read the 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.
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.
- Conditions
- Pain Management
- Being tested
- Bupivacaine/Epinephrine, Saline
- Keywords
- otolaryngology, surgery, facial plastic, trauma
- Medical subject headings
- Agnosia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine/EpinephrineDrug
injection
SalineDrug
injection
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine injection | Experimental | 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. Receives: Drug: Bupivacaine/Epinephrine |
| Saline injection | Placebo comparator | 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs).
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.
Measured: day 1 or the day of surgery
Secondary outcomes (1)
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.
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.
Measured: within 1 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start2 Apr 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, placebo-controlled randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amrita Hari_Raj, MD, Principal investigator, Washington University School of MedicineJay Piccirillo, MD, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429501
- Sponsor's protocol ID
- 202401085
- Acronym
- LAFF
- Status last verified
- Feb 2026
- First submitted
- 23 Apr 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedegaard H, Minino AM, Spencer MR, Warner M. Drug Overdose Deaths in the United States, 1999-2020. NCHS Data Brief. 2021 Dec;(426):1-8.
PubMed 34978529Abraham AJ, Rieckmann T, Gu Y, Lind BK. Inappropriate Opioid Prescribing in Oregon's Coordinated Care Organizations. J Addict Med. 2020 Jul/Aug;14(4):293-299. doi: 10.1097/ADM.0000000000000569.
PubMed 31609864BJC Healthcare. Level I Trauma Center. Barnes-Jewish Hospital. https://www.barnesjewish.org/Medical-Services/Trauma-Acute-CareSurgery/Level-I-Trauma-Center
Lapidus JB, Santosa KB, Skolnick GB, Som A, Cho GJ, Waljee JF, AuBuchon JD, Patel KB. Opioid Prescribing and Use Patterns in Postsurgical Facial Trauma Patients. Plast Reconstr Surg. 2020 Mar;145(3):780-789. doi: 10.1097/PRS.0000000000006588.
PubMed 32097326Perloff MD, Chung JS. Urgent care peripheral nerve blocks for refractory trigeminal neuralgia. Am J Emerg Med. 2018 Nov;36(11):2058-2060. doi: 10.1016/j.ajem.2018.08.019. Epub 2018 Aug 8.
PubMed 30119988Staity G, Saadi RA, Pool C, Lighthall JG. The Safety Profile of Liposomal Bupivacaine Use in Septorhinoplasty. Facial Plast Surg Aesthet Med. 2022 May-Jun;24(3):202-206. doi: 10.1089/fpsam.2020.0544. Epub 2021 Feb 22.
PubMed 33617355Schumacher JK, Cristel RT, Talugula S, Shah AR. The Use of Adjunctive Perioperative Nerve Blocks in Rhinoplasty in the Immediate Postoperative Period. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):361-362. doi: 10.1089/fpsam.2022.0125. Epub 2022 Sep 14. No abstract available.
PubMed 36106969The University of Iowa Otolaryngology Protocols. https://medicine.uiowa.edu/iowaprotocols/maximum-recommended-doses-andduration-local-anesthetics
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06429501
- Acronym / sponsor ID
- LAFF / 202401085
- Conditions
- Pain Management
- Keywords
- otolaryngology, surgery, facial plastic, trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, placebo-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine injection | Experimental | Drug: Bupivacaine/EpinephrineThe 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 | Placebo comparator | Drug: SalineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 and over
- Isolated facial fracture to the mandible and/or midface undergoing surgical repair
- No allergy to local anesthetic
- Ability to read, write, and understand English
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Isolated nasal bone fracture
- Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)
- Allergy to local anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine/Epinephrineinjection | Drug | Bupivacaine injection |
| Salineinjection | Drug | Saline injection |
Primary outcome
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
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.
1 secondary outcome
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.
Time frame: within 1 month post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 34978529Hedegaard H, Minino AM, Spencer MR, Warner M. Drug Overdose Deaths in the United States, 1999-2020. NCHS Data Brief. 2021 Dec;(426):1-8.
- Background: PubMed 31609864Abraham AJ, Rieckmann T, Gu Y, Lind BK. Inappropriate Opioid Prescribing in Oregon's Coordinated Care Organizations. J Addict Med. 2020 Jul/Aug;14(4):293-299. doi: 10.1097/ADM.0000000000000569.
- BackgroundBJC Healthcare. Level I Trauma Center. Barnes-Jewish Hospital. https://www.barnesjewish.org/Medical-Services/Trauma-Acute-CareSurgery/Level-I-Trauma-Center
- Background: PubMed 32097326Lapidus JB, Santosa KB, Skolnick GB, Som A, Cho GJ, Waljee JF, AuBuchon JD, Patel KB. Opioid Prescribing and Use Patterns in Postsurgical Facial Trauma Patients. Plast Reconstr Surg. 2020 Mar;145(3):780-789. doi: 10.1097/PRS.0000000000006588.
- Background: PubMed 30119988Perloff MD, Chung JS. Urgent care peripheral nerve blocks for refractory trigeminal neuralgia. Am J Emerg Med. 2018 Nov;36(11):2058-2060. doi: 10.1016/j.ajem.2018.08.019. Epub 2018 Aug 8.
- Background: PubMed 33617355Staity G, Saadi RA, Pool C, Lighthall JG. The Safety Profile of Liposomal Bupivacaine Use in Septorhinoplasty. Facial Plast Surg Aesthet Med. 2022 May-Jun;24(3):202-206. doi: 10.1089/fpsam.2020.0544. Epub 2021 Feb 22.
- Background: PubMed 36106969Schumacher JK, Cristel RT, Talugula S, Shah AR. The Use of Adjunctive Perioperative Nerve Blocks in Rhinoplasty in the Immediate Postoperative Period. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):361-362. doi: 10.1089/fpsam.2022.0125. Epub 2022 Sep 14. No abstract available.
- BackgroundThe University of Iowa Otolaryngology Protocols. https://medicine.uiowa.edu/iowaprotocols/maximum-recommended-doses-andduration-local-anesthetics
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amrita Hari_Raj, MD principal investigator
Washington University School of Medicine
Jay Piccirillo, MD study director
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine/Epinephrine and Saline in people with Pain Management, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amrita Hari-Raj, MD (314-518-6410, amrita.hari-raj@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06429501, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.