Local Anesthesia for Pain Management in Facial Fractures

(LAFF Trial)

Recruiting at 1 trial location

Overseen By Amrita Hari-Raj, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Under 18, Nasal fracture, Polytrauma, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the local anesthetic bupivacaine can manage pain in individuals with facial fractures during surgery. Participants will receive either a bupivacaine injection or a placebo (a harmless substance with no treatment effect) before waking from anesthesia. The researchers aim to determine if bupivacaine improves recovery immediately after surgery. This trial suits adults needing surgery for a broken jaw or midface, who do not have an allergy to local anesthetics and can understand English. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that bupivacaine is likely to be safe for humans?

A previous study showed that bupivacaine can reduce the need for opioids in patients experiencing post-surgical pain, suggesting it might be a good option for pain relief. However, research has also indicated that some local painkillers, including bupivacaine, can harm nerve cells. While bupivacaine is generally considered safe, there is a risk of nerve damage, especially if not used correctly.

Since this trial is in an early phase, researchers are still gathering information on the safety of bupivacaine for this specific use. Bupivacaine is already used in other medical situations, supporting its general safety, but its specific effects on facial fractures are still under study. Participants should be aware of both the potential benefits and risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for facial fracture pain involve systemic pain relief methods like opioids or NSAIDs, which can have significant side effects. Bupivacaine is unique because it offers localized pain management through a nerve block, potentially reducing the need for these systemic medications and their associated risks. Researchers are excited about bupivacaine because it targets pain directly at the source with a long-lasting effect, offering a promising, safer alternative for managing pain in facial fractures.

What evidence suggests that bupivacaine might be an effective treatment for pain management in facial fractures?

Research shows that bupivacaine can help manage pain after surgery. In this trial, participants will receive either a bupivacaine injection or a saline injection as a placebo comparator. One study found that bupivacaine reduced pain in patients with facial fractures after surgery by numbing nerves. As a result, patients needed fewer opioids, which are strong painkillers with potential side effects. Another review found that bupivacaine helped with pain in surgeries involving the mouth and face. These findings suggest that bupivacaine can effectively control pain after facial surgeries, potentially making recovery smoother and faster. ^{1 3 4 6 7}

Who Is on the Research Team?

Jay Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Amrita Hari_Raj, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with facial fractures requiring surgery. Participants must be eligible for the surgical procedure and able to receive injections prior to anesthesia emergence. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

No allergy to local anesthetic

Ability to read, write, and understand English

I am having surgery for a broken jaw or facial bones.

Exclusion Criteria

Allergy to local anesthetic

Isolated nasal bone fracture

I was hospitalized for multiple bone fractures not including the face.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bupivacaine or saline injections prior to anesthesia emergence for facial fracture surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for opioid and antiemetic use, pain score, and recovery metrics post-surgery

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview The study tests if bupivacaine nerve blocks help with pain management after surgery compared to saline (a placebo). Patients are randomly assigned to get either the real drug or a placebo without knowing which one they received.

How Is the Trial Designed?

Group I: Bupivacaine injection Experimental Treatment 1 Intervention

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.

Group II: Saline injection Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Bupivacaine hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.

It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. Babst, CR., Gilling, BN.[2018]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

Bupivacaine, used in various concentrations (0.25%, 0.5%, 0.75%) for different types of anesthesia, consistently provided complete sensory anesthesia for a wide range of surgical procedures, with onset times of 4 to 10 minutes and maximum effect in 15 to 35 minutes.

While there were 15 reported systemic toxic reactions, none led to lasting harm, indicating that Bupivacaine can be used safely in clinical settings, although careful monitoring is necessary, especially with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. Moore, DC., Bridenbaugh, LD., Thompson, GE., et al.[2019]

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

Patients receiving bupivacaine liposome (Exparel) reported significantly lower pain levels and consumed fewer opioid pills on the day of surgery compared to those receiving standard bupivacaine (Marcaine).

However, the benefits of Exparel in reducing pain and opioid use were not sustained beyond the day of surgery, as no significant differences were observed in pain levels or total opioid consumption in the following days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Study Comparing Bupivacaine Hydrochloride Versus Bupivacaine Liposome for Pain Management After Distal Radius Fracture Repair Surgery. Alter, TH., Liss, FE., Ilyas, AM.[2018]

Wound perfusion with bupivacaine provides effective and sustained postoperative pain relief without any complications or side effects, indicating its safety for use in patients.

Both intermittent and continuous wound perfusion significantly reduced postoperative pain and analgesic requirements, suggesting that this technique can enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? Thomas, DF., Lambert, WG., Williams, KL.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11562988/

Pain Management in Surgical Treatment of Facial Fractures According to a meta-analysis specifically assessing post-operative pain after nasal surgery, however, bupivacaine was found to have better pain ...

2. trialx.com trialx.com/clinical-trials/listings/315098/local-anesthesia-for-facial-fractures/

Local Anesthesia for Facial Fractures The purpose of the study is to define whether a perioperative bupivacaine nerve block results in a decrease in the amounts of opioids and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06243263

Postoperative Pain After Bupivacaine Supplementation in ... The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures. The main ...

4. joma.amegroups.org joma.amegroups.org/article/view/5618/html

Liposomal bupivacaine: a literature review of applications in ... Conclusions: Liposomal bupivacaine may be a promising tool to adequately manage postoperative pain and limit opioid doses following OMS procedures. Future ...

5. iosrjournals.org iosrjournals.org/iosr-jdms/papers/Vol24-issue5/Ser-4/K2405045458.pdf

Management Of Pain In Mandibular Fracture By ... postoperative bupivacaine administration did not demonstrate a higher analgesic efficacy in managing acute postoperative pain following BSSO.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7367228/

Distinct neurotoxic effects of select local anesthetics on ... Our data demonstrate that some local anesthetics, but not all, exacerbate motoneuron death and delay functional recovery after a peripheral nerve injury.

7. entnet.org entnet.org/wp-content/uploads/files/ResidentTraumaFINALhighres.pdf

Resident Manual of Trauma to the Face, Head, and Neck Incidence of eye injuries in facial fractures: An analysis of 727 cases ... outcomes of pediatric facial fractures in the US: A survey of the. National ...