Local Anesthesia for Pain Management in Facial Fractures

(LAFF Trial)

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

Trial Summary

What is the purpose of this 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.

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.

What data supports the effectiveness of the drug Bupivacaine, Marcaine, Sensorcaine for pain management in facial fractures?

Research shows that Bupivacaine (also known as Marcaine or Sensorcaine) is effective in managing pain due to its long-lasting effects and minimal side effects, as seen in oral surgery and breast reduction procedures. It provides good pain relief and reduces the need for additional pain medication. ^{1 2 3 4 5}

Is Bupivacaine (Marcaine, Sensorcaine) safe for use in humans?

Bupivacaine (also known as Marcaine or Sensorcaine) is generally considered safe for use in humans when used in recommended doses. It has been used effectively for pain relief in various medical procedures, with minimal side effects reported when proper dosing guidelines are followed. ^{1 2 3 5 6}

How does the drug bupivacaine differ from other treatments for pain management in facial fractures?

Bupivacaine is unique because it is a long-acting local anesthetic that provides extended pain relief compared to other local anesthetics. It is administered directly to the affected area, which can reduce the need for oral narcotics and their associated side effects. ^{1 5 6 7 8}

Research Team

Amrita Hari_Raj, MD

Principal Investigator

Washington University School of Medicine

Jay Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

I am 18 years old or older.

Ability to read, write, and understand English

Exclusion Criteria

Allergy to local anesthetic

Isolated nasal bone fracture

I am younger than 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

3. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

4. England pubmed.ncbi.nlm.nih.gov

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? [2018]

5. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Study Comparing Bupivacaine Hydrochloride Versus Bupivacaine Liposome for Pain Management After Distal Radius Fracture Repair Surgery. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. [2019]