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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine if there is a difference in post-operative pain after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia compared to other standard local anesthetic regimens.

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.

What data supports the effectiveness of the drug Liposomal Bupivacaine for pain management after a nose job?

Research shows that liposomal bupivacaine, a long-acting form of a local anesthetic, has been used to improve pain control in some surgeries, like pharyngoplasty, and can extend pain relief for several days. However, overall evidence suggests it may not be more effective than standard local anesthetics in many cases. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for use in humans?

Liposomal bupivacaine (Exparel) has been shown to be safe in various surgical settings, including pediatric patients undergoing pharyngoplasty and adults undergoing breast augmentation. It is approved for use in the United States for pain management after surgery, and safety data from clinical trials support its use in humans. ^{1 2 5 6 7}

How is liposomal bupivacaine different from other drugs for pain management after a 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 off more quickly. This extended-release formulation helps reduce the need for additional pain medication, such as opioids, after a nose job. ^{2 8 9 10 11}

Research Team

Jessyka Lighthall, MD

Principal Investigator

Penn State Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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 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]

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]

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 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]

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]

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 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]

References

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

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]

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

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]

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

Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. [2022]

4. United States 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. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]

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

Bupivacaine liposomal versus bupivacaine: comparative review. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Intraoperative liposomal bupivacaine for skin graft donor site analgesia: A retrospective cohort study. [2021]