Liposomal Bupivacaine for Post-Surgery Pain in Fibroids

Overseen by Daniel Katz, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Epilepsy, Seizure disorder, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

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 data supports the effectiveness of the drug 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 opioids, which are strong painkillers with side effects. This suggests it could be effective for managing post-surgery pain in fibroid treatments as well. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for humans?

Liposomal bupivacaine, also known as Exparel, has been shown to be safe in various surgical settings, including breast augmentation and reduction mammaplasty, based on multiple studies and post-marketing safety reviews. ^{4 6 7 8 9}

How is liposomal bupivacaine different from other drugs for post-surgery pain in fibroids?

Liposomal bupivacaine is unique because it is a long-acting form of bupivacaine that is designed to be released slowly over time, providing extended pain relief after surgery. This can potentially reduce the need for additional pain medications, such as opioids, compared to traditional bupivacaine. ^{8 10 11 12 13}

Research Team

Daniel Katz, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic)
• Bupivacaine liposome (Local Anesthetic)

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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 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 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]

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]

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]

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]

References

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

Liposomal Bupivacaine Injection for Analgesia During Minimally Invasive Supracervical Hysterectomy. [2022]

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

Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. [2022]

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

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

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

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

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

Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial. [2022]

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

The safety of liposome bupivacaine, a novel local analgesic formulation. [2022]

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

Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. [2019]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany 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. [2021]

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

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

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

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]

12. 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]

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

Bupivacaine liposomal versus bupivacaine: comparative review. [2021]