Liposomal Bupivacaine for Post-Surgery Pain in Fibroids

Overseen By Daniel Katz, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Epilepsy, Seizure disorder, others

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

Compensation: Varies

Number of Visits: 49

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to manage pain after fibroid surgery. Researchers are testing two types of bupivacaine to determine if they can reduce the need for opiate painkillers post-surgery. One group receives a standard form of bupivacaine, while the other receives a newer, liposomal version, which may offer longer-lasting pain relief. This trial suits individuals undergoing open myomectomy (surgery for fibroids) who weigh over 50 kg and do not have certain medical conditions or allergies. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients, offering participants a chance to contribute to broader medical knowledge.

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 study team or your doctor.

What is the safety track record for these treatments?

Research has shown that liposomal bupivacaine, used to relieve post-surgical pain, is generally well-tolerated. In one study, fewer than 2% of patients experienced less common side effects, such as chills, a slow heart rate, and anxiety. Another study found that liposomal bupivacaine significantly reduced pain for up to 72 hours after surgery.

Regular bupivacaine, a well-known local anesthetic, blocks pain during surgeries and has been used safely for many years.

Both treatments aim to reduce post-surgical pain. Studies suggest they are safe and have a low risk of side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for post-surgery pain in fibroids involve standard painkillers and local anesthetics like standard bupivacaine. But researchers are excited about liposomal bupivacaine because it offers a new delivery method that could extend pain relief. Unlike standard bupivacaine, which releases its active ingredient quickly, liposomal bupivacaine uses tiny, fat-like particles to slowly release the medication over time. This means it might keep pain at bay for longer after surgery, potentially reducing the need for additional pain medication.

What evidence suggests that liposomal bupivacaine might be an effective treatment for post-surgery pain in fibroids?

This trial will compare the effectiveness of liposomal bupivacaine with standard bupivacaine for managing post-surgery pain in fibroid surgery. Research has shown that liposomal bupivacaine can reduce pain after surgeries like hysterectomies and cesarean deliveries and may decrease the need for opioids, which are strong pain medicines. However, some studies found no difference in pain relief when compared to a placebo in certain surgeries. This suggests that while liposomal bupivacaine can be effective, its success may depend on the type of surgery. For fibroid surgery, the aim is to lessen pain and reduce the need for opioids. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel Katz, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals over 50kg who are scheduled for open myomectomy surgery to remove fibroids and do not have a history of allergies to study medications, drug or alcohol abuse, liver disease, severe heart rhythm problems, epilepsy, seizures, or chronic pain other than from myomas.

Inclusion Criteria

Not pregnant

I weigh more than 50kg and am preparing for open surgery to remove fibroids.

You have never had an allergic reaction to any of the study drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine post induction and pre incision

Immediate (during surgery)

1 visit (in-person)

Follow-up

Participants are monitored for opiate consumption, pain scores, side effects, and recovery for up to 96 hours

4 days

Follow-up assessments at 48, 72, and 96 hours

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Bupivacaine liposome

Trial Overview The trial is testing the effectiveness of two types of local anesthetics: liposomal bupivacaine versus standard bupivacaine. Patients will be randomly assigned to receive one of these during their surgery. The main focus is on whether these anesthetics reduce the need for opioid pain relief after surgery.

How Is the Trial Designed?

Group I: Liposomal bupivacaine TAP Experimental Treatment 3 Interventions

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

Group II: Bupivacaine TAP Placebo Group 2 Interventions

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study of 90 patients undergoing immediate breast reconstruction, the use of liposomal bupivacaine (LB) significantly reduced postoperative pain scores compared to traditional pain management methods, indicating its efficacy as a pain reliever.

Patients receiving LB also had a shorter hospital stay (1.5 days) compared to those on narcotics (2.0 days), with no reported adverse events, highlighting its safety and potential benefits in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Butz, DR., Shenaq, DS., Rundell, VL., et al.[2022]

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 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).

The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. Jacobus, D., Mehr, S., Ziccardi, V.[2021]

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]

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 significantly reduced opioid use in patients undergoing complex cytoreductive surgery, with lower median oral morphine equivalents and fewer patients requiring intravenous rescue opioids compared to bupivacaine hydrochloride.

Despite the higher cost of liposomal bupivacaine, it did not lead to increased total pharmacy costs, and both groups reported similar pain scores, indicating its efficacy in managing pain without increasing opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. Kalogera, E., Bakkum-Gamez, JN., Weaver, AL., et al.[2022]

In a study involving 80 opioid-naive women undergoing cesarean delivery, the use of a liposomal bupivacaine incisional block did not significantly reduce postoperative pain scores compared to a placebo, with median pain scores of 4 in the bupivacaine group and 3.5 in the placebo group at 48 hours post-surgery.

Opioid consumption was also similar between the two groups, with both groups using a median of 37.5 morphine milligram equivalents in the first 48 hours, indicating that liposomal bupivacaine did not effectively minimize opioid use after cesarean delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial. Prabhu, M., Clapp, MA., McQuaid-Hanson, E., et al.[2022]

In a study involving 823 patients across various surgical settings, liposome bupivacaine demonstrated a lower incidence of adverse events (62%) compared to bupivacaine HCl (75%) and placebo (43%), indicating better tolerability.

Serious adverse events were less common in the liposome bupivacaine group (2.7%) compared to bupivacaine HCl (5.4%), suggesting that liposome bupivacaine may be a safer option for local analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. Viscusi, ER., Sinatra, R., Onel, E., et al.[2022]

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]

Liposome bupivacaine is a promising alternative for post-surgical pain management, potentially reducing the need for opioids and their associated adverse effects, based on clinical trial data and safety reviews.

This liposomal formulation allows for a single administration directly at the surgical site, which may enhance pain control while minimizing risks linked to traditional opioid analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine 2 years post-launch: a look back and a look forward. Viscusi, ER.[2022]

In a study involving 60 women undergoing minimally invasive supracervical hysterectomy, the use of intracervical liposomal bupivacaine did not significantly reduce postoperative pain compared to a placebo, with similar pain scores recorded at various time points up to 48 hours post-surgery.

There was no difference in the number of patients requiring opioid pain relief between the group receiving liposomal bupivacaine and the placebo group, indicating that the treatment did not provide a meaningful advantage in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Injection for Analgesia During Minimally Invasive Supracervical Hysterectomy. Son, MA., Jiggetts, S., Elfeky, A., et al.[2022]

Liposomal bupivacaine significantly reduced postoperative pain and the need for antiemetics in certain obesity classes, particularly showing lower pain scores immediately after surgery and at discharge for obesity class I patients.

Patients receiving liposomal bupivacaine had shorter hospital stays, especially among premenopausal women, indicating potential benefits in recovery time and overall patient outcomes compared to standard bupivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. Kalaria, SS., Boukovalas, S., Padilla, PL., et al.[2019]

In a randomized controlled trial involving 57 patients undergoing midurethral sling placement, liposomal bupivacaine resulted in lower median pain scores on postoperative day 1 compared to a mixture of bupivacaine and lidocaine (20 mm vs 30 mm), indicating some efficacy in pain management.

Despite the initial lower pain scores, there were no significant differences in overall opioid and nonsteroidal anti-inflammatory drug consumption or in quality of recovery scores after 7 days, suggesting that liposomal bupivacaine may not provide a clinically significant advantage over traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. Iwanoff, C., Salamon, C.[2020]

Citations

1. withpower.com withpower.com/trial/phase-4-leiomyoma-10-2020-a454a

Liposomal Bupivacaine for Post-Surgery Pain in Fibroids Research shows that liposomal bupivacaine can help reduce pain after surgeries like hysterectomy and cesarean delivery, and it may also lower the need for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30273586/

Liposomal bupivacaine efficacy for postoperative pain ... Previous studies have reported the beneficial use of a single intraoperative injection of extended-release liposomal bupivacaine in postoperative pain ...

3. researchgate.net researchgate.net/publication/327948577_Liposomal_Bupivacaine_Efficacy_for_Post-Operative_Pain_Following_Posterior_Vaginal_Surgery_A_Randomized_Double-Blind_Placebo_Controlled_Trial

Liposomal Bupivacaine Efficacy for Post-Operative Pain ... 8 Results demonstrated no difference in pain scores among women who received an injection of liposomal bupivacaine intraoperatively vs. placebo ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03152877

Efficacy of Extended-Release Liposomal Bupivacaine for ... We propose a prospective, randomized, single blinded trial with subjects recruited from the WRNMMC Labor and Delivery Unit to study post-partum efficacy of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9255262/

Liposomal Bupivacaine Injection for Analgesia During ... There was no statistically significant difference in pain scores between patients receiving combination liposomal bupivacaine and bupivacaine intracervical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3772762/

Liposomal extended-release bupivacaine for postsurgical ... The double-blinded study found that the cumulative pain intensity scores through 4 days postsurgery were 20.7, 19.5, 18.8, and 19.1, for using EXPAREL® at doses ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/022496s9lbl.pdf

EXPAREL (bupivacaine liposome injectable suspension) The less common/rare adverse reactions (incidence less than 2%) following EXPAREL administration were chills, erythema, bradycardia, anxiety, urinary retention, ...

8. aetna.com aetna.com/cpb/medical/data/900_999/0941.html

Bupivacaine Liposome (Exparel) - Medical Clinical Policy ... The authors concluded that bupivacaine extended-release demonstrated a statistically significant reduction in pain through 72 hours, decreased opioid ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/bupivacaine-liposome-injection-route/description/drg-20075313

Bupivacaine liposome (injection route) - Side effects & uses Bupivacaine liposome injection is used to relieve pain after surgery. It is a local anesthetic that prevents pain by blocking signals at the nerve endings.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2468428725000784

Liposomal bupivacaine infiltration for postprocedural ... These findings suggest that LB is safe to use for postprocedural analgesia in pediatric and adult patients undergoing painful interventions for vascular ...