Liposomal Bupivacaine for Pain Management After Nose Job

Overseen By Jessyka Lighthall, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jessyka Lighthall

Must not be taking: Narcotics

Disqualifiers: Pregnancy, Cognitive impairment, Liver dysfunction, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing pain after rhinoplasty using a long-lasting local anesthetic called liposomal bupivacaine. Researchers aim to determine if it is more effective than standard pain relief methods, such as regular bupivacaine with epinephrine or saline. Candidates for this study include those undergoing rhinoplasty or septorhinoplasty who do not have certain health conditions, such as liver problems or chronic pain issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are already taking narcotics for chronic pain.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found liposomal bupivacaine to be safe for individuals undergoing septorhinoplasty, a type of nose surgery. It showed no major differences in side effects compared to other treatments. The complication rate, including infections, was about 3.2%, which is considered low. Notably, this form of bupivacaine is already approved in the U.S. for managing post-surgical pain, supporting its safety.

Research indicates that bupivacaine with epinephrine poses no significant risks, such as increased bleeding during or after surgery. This combination is commonly used in surgeries to reduce bleeding and manage pain, and it has a strong safety record.

Overall, past studies have shown both treatments to be well-tolerated, suggesting they are safe for individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Liposomal bupivacaine is unique because it offers a long-lasting pain relief option after a nose job by using a slow-release mechanism that prolongs the effects of the anesthetic. Traditional treatments like standard bupivacaine with epinephrine provide shorter durations of pain relief, often requiring additional medication. Researchers are excited about liposomal bupivacaine because it could reduce the need for opioids and frequent dosing, potentially leading to a more comfortable recovery with fewer side effects. Additionally, the one-time injection at the surgical site simplifies pain management for both patients and healthcare providers.

What evidence suggests that this trial's treatments could be effective for pain management after a nose job?

In this trial, participants will receive one of three treatments for pain management after nose surgery (rhinoplasty). Research has shown that liposomal bupivacaine, one of the treatments being tested, effectively manages pain and provides relief for up to 72 hours, potentially reducing the need for opioids. Studies indicate that it reduces pain levels and is generally safe and well-tolerated.

Another treatment option in this trial is bupivacaine with epinephrine, commonly used for numbing during and after surgery. While effective, its effects do not last as long as liposomal bupivacaine. Overall, liposomal bupivacaine may offer longer-lasting pain relief. ^{1 4 6 7 8}

Who Is on the Research Team?

Jessyka Lighthall, MD

Principal Investigator

Penn State Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having nose surgery (rhinoplasty or septorhinoplasty) and can give written consent. It's not for pregnant women, prisoners, those under 48 kg, with liver issues or high creatinine levels, morbid obesity, cognitive impairments, allergies to local anesthetics/pain meds used in the study, chronic pain medication users before surgery, or those with pre-existing painful conditions.

Inclusion Criteria

Written informed consent must be obtained

I am scheduled for a nose surgery or nose and septum surgery.

Exclusion Criteria

Patients with hypersensitivity to local anesthetics and pain medications used in the study

I weigh less than 48 kg.

I am taking pain medication regularly before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time 5 mL injection of either liposomal bupivacaine, saline, or bupivacaine with epinephrine post-operatively at the surgical site

Immediate post-operative period

1 visit (in-person)

Immediate Post-operative Monitoring

Participants' use of postoperative pain medications is documented in the post-anesthesia care unit (PACU) and daily for the following week

1 week

Daily monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain assessment and clinical exams

6 months

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 0.25% bupivacaine with 1:200,000 epinephrine
• Liposomal Bupivacaine
• Placebo - Saline solution

Trial Overview The trial tests if liposomal bupivacaine provides better post-surgery pain relief after a nose job compared to standard local anesthesia (0.25% bupivacaine with epinephrine) or placebo (saline solution). Participants will receive one of these treatments randomly.

How Is the Trial Designed?

Group I: Liposomal Bupivacaine Experimental Treatment 1 Intervention

This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.

Group II: Bupivacaine with epinephrine Active Control 1 Intervention

This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.

Group III: Saline solution Placebo Group 1 Intervention

This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Who Is Running the Clinical Trial?

Jessyka Lighthall

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

Liposomal bupivacaine, administered in single or repeated doses, showed a maximum plasma concentration (C max) that remained well below the toxicity thresholds for neurotoxicity and cardiac toxicity, indicating a strong safety profile.

The study demonstrated that both single and repeated doses of liposomal bupivacaine were well-tolerated in healthy volunteers, with no significant adverse effects on neurologic or cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers. Rice, D., Heil, JW., Biernat, L.[2018]

In a study of 34 patients undergoing breast augmentation, liposomal bupivacaine provided statistically significant lower pain scores compared to standard bupivacaine at multiple time points post-surgery, indicating it may offer better pain control.

Despite the statistical significance, the differences in pain relief were small, and 70% of patients felt the additional cost of liposomal bupivacaine was not justified by the benefits, suggesting limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Nadeau, MH., Saraswat, A., Vasko, A., et al.[2022]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

Bupivacaine liposomal injection has been approved by the FDA as a local anesthetic for managing postsurgical pain in adults, showing significant efficacy in reducing postoperative pain and opioid use compared to placebo.

This review compares the efficacy of bupivacaine liposomal to conventional bupivacaine with or without epinephrine, utilizing both published and unpublished data submitted to the FDA by the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine liposomal versus bupivacaine: comparative review. Noviasky, J., Pierce, DP., Whalen, K., et al.[2021]

A review of 76 randomized controlled trials found that only 11% showed a significant benefit of liposomal bupivacaine over standard bupivacaine or ropivacaine for postoperative pain control.

The majority of trials indicated that unencapsulated bupivacaine provided better pain relief than liposomal bupivacaine, suggesting that routine use of liposomal bupivacaine may not be justified based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Ilfeld, BM., Eisenach, JC., Gabriel, RA.[2021]

Liposomal bupivacaine (Exparel) has been shown to be a safe and effective option for managing postoperative pain in plastic surgery, based on a review of eight studies involving 405 patients.

Compared to traditional pain management methods, liposomal bupivacaine was found to be equivalent or more effective, suggesting it could serve as a less invasive alternative to more complex pain management systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Vyas, KS., Rajendran, S., Morrison, SD., et al.[2022]

In a study involving 100 patients with pulpal necrosis, liposomal bupivacaine did not show a statistically significant improvement in postoperative pain relief compared to standard bupivacaine, with success rates of 29% and 22% respectively.

While liposomal bupivacaine had some effects on soft tissue numbness and non-narcotic medication use, these effects were not clinically significant, indicating that it may not provide additional benefits over traditional bupivacaine for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. Glenn, B., Drum, M., Reader, A., et al.[2017]

In a study of 50 patients undergoing vaginal reconstructive surgery, liposomal bupivacaine (LB) did not show any significant advantage over plain bupivacaine in terms of postoperative pain control, narcotic use, or length of hospital stay.

Despite LB's higher cost, the results indicate that it is not more effective than plain bupivacaine for managing pain after surgery, suggesting a need for further research to find the best pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. Jensen, S., Amasyali, AS., Keheila, M., et al.[2023]

In a study of 58 patients undergoing skin graft procedures, those who received liposomal bupivacaine reported significantly lower donor site pain on postoperative days 0 and 1, with 86% rating their pain as three or less, compared to only 3.4% in the control group.

Liposomal bupivacaine not only reduced pain levels but also made the donor site less bothersome for patients, with 76% stating it was less painful than the graft site, indicating its potential as a safe and effective option for prolonged postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative liposomal bupivacaine for skin graft donor site analgesia: A retrospective cohort study. Artz, C., Ward, MA., Miles, MVP., et al.[2021]

Liposomal bupivacaine (LB) is safe for use in pediatric patients and significantly improves pain control after pharyngoplasty, as evidenced by lower pain scores compared to those receiving standard lidocaine.

Patients treated with LB had earlier oral intake, required fewer opioids, and were discharged from the hospital nearly 2 days earlier than those in the control group, highlighting its efficacy in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. Day, KM., Nair, NM., Griner, D., et al.[2018]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

Citations

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Evaluating the Efficacy of Liposomal Bupivacaine in ... Liposomal bupivacaine presents as an efficacious alternative for post-rhinoplasty pain management, reducing both perceived pain and opioid consumption.

2. withpower.com withpower.com/trial/phase-3-rhinoplasty-8-2023-952cd

Liposomal Bupivacaine for Pain Management After Nose Job Liposomal bupivacaine is unique because it provides long-lasting pain relief for up to 72 hours after surgery, unlike traditional local anesthetics that wear ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10393085/

Effective Local Anesthetic Use in Nasal Surgery: A Systematic ... Intraoperative nerve blocks have shown promise in managing pain after nasal surgery. The purpose of this systematic review and meta-analysis ...

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Evaluating the Efficacy of Liposomal Bupivacaine in ... The findings indicate that patients receiving liposomal bupivacaine experienced significantly lower pain scores postoperatively and less overall opioid ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/fpsam.2020.0544

The Safety Profile of Liposomal Bupivacaine Use in ... Current studies show mixed results in the use of LB in the reduction of postsurgical pain and opioid use, but some evidence suggests increased efficacy ...

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Can Elimination of Epinephrine in Rhinoplasty Reduce the ... We found (1) no statistically significant association between epinephrine injection and hemorrhage during or after surgery (P = 0.949), (2) a statistically ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04377204

The Utility of Long-acting Local Anesthetic Agents in ... The study herein would like to examine the pain outcomes of enrolled patients who will either have lidocaine alone OR lidocaine+bupivacaine combination locally ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2950553424000406

Anesthesia for rhinoplasty: A summary of clinical ... Anesthesia for rhinoplasty: A summary of clinical considerations, therapeutic modalities, outcomes, and future directions.