Pecs Blocks + Exparel for Breast Reduction Surgery

Overseen By Mahesh Vaidyanathan, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Northwestern University

Disqualifiers: Flap surgery, Radiation therapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a pain relief method for individuals undergoing breast reconstruction surgery. It compares two approaches to using pain blockers during surgery: one with only bupivacaine (a local pain reliever) and the other with a combination of bupivacaine and Exparel (a non-opioid pain reliever). The aim is to determine if this method can reduce pain and the need for opioids after surgery, while also promoting patient activity. Individuals undergoing implant-based breast reconstruction (excluding flap or direct-to-implant surgery) may be suitable candidates for this trial. As a Phase 3 trial, this research represents the final step before FDA approval, providing participants the opportunity to contribute to a potentially groundbreaking pain management solution.

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.

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

Research has shown that using Pecs blocks with Exparel is safer than some other nerve blocks for breast surgery. This method reduces the need for opioids after surgery, benefiting patients who prefer to manage pain without strong drugs. The FDA has approved Exparel for surgeries like breast reconstruction, confirming its safety through rigorous testing.

In past studies, patients who received Pecs blocks with Exparel required fewer opioids and experienced less pain afterward. This combination also reduced post-surgery nausea, leading to a smoother recovery. Overall, Pecs blocks with Exparel appear well-tolerated and could be a good option for managing pain without relying on opioids. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using a combination of bupivacaine and Exparel for breast reduction surgery because it offers enhanced pain control compared to traditional methods. Unlike standard treatments that use bupivacaine alone, this approach includes Exparel, which provides prolonged pain relief by slowly releasing the anesthetic over time. This could potentially reduce the need for additional pain medications post-surgery, making recovery smoother for patients. Additionally, by using a mixture of bupivacaine and Exparel, surgeons aim to balance immediate and sustained pain relief, addressing both intra-operative and post-operative pain more effectively.

What evidence suggests that this trial's treatments could be effective for breast reconstruction surgery?

Research has shown that using Pecs blocks with Exparel during breast reconstruction surgery effectively controls pain. In this trial, one group of participants will receive Pecs blocks with a mixture of bupivacaine and Exparel, while another group will receive Pecs blocks with bupivacaine alone. Studies have found that patients who received these blocks needed fewer narcotics after surgery compared to those who did not. Another study found that this method can reduce the need for opioids and manage pain well during the procedure. The FDA has approved Exparel for use in breast reconstruction, and it has been shown to lessen pain and post-surgical nausea. These findings suggest that this treatment approach could improve recovery after surgery. ^{1 3 4 5 6}

Who Is on the Research Team?

Robert Galiano, MD

Principal Investigator

3126956022

Are You a Good Fit for This Trial?

This trial is for individuals over 18 years old who are having implant-based, tissue expander breast reconstruction surgery. It's not suitable for those with prior radiation therapy, direct-to-implant or flap reconstruction surgeries, pregnant women, or anyone with conditions that could risk participation or skew results.

Inclusion Criteria

I am over 18 years old.

I am having breast reconstruction with implants or tissue expanders.

Exclusion Criteria

I am having surgery to place breast implants without tissue expanders.

I am having breast reconstruction using the flap technique.

Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast reconstruction surgery with Pecs blocks and Exparel administration

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for opioid consumption, nausea, mobility, and pain outcomes

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breast Reconstruction (Mammaplasty)
• Bupivacaine
• Exparel
• Lidocaine
• Pecs blocks

Trial Overview The study examines the effectiveness of Pecs blocks combined with Exparel in managing pain after breast reconstruction surgery. The goal is to see if this method reduces post-operative pain and opioid use while improving physical activity without using opioids.

How Is the Trial Designed?

Group I: Blocks+Bupivacaine+Exparel Experimental Treatment 4 Interventions

Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel)

Group II: Blocks+Bupivacaine Active Control 3 Interventions

Use of Pecs block types I and II with bupivacaine as local anesthetic

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Pacira Pharmaceuticals, Inc

Industry Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Published Research Related to This Trial

In a study of 36 patients undergoing breast reductions, Pectoralis nerve (Pecs) blocks did not significantly reduce perioperative narcotic requirements, pain scores, or the need for antiemetic medication compared to general anesthesia alone.

However, the use of Pecs blocks was associated with a longer operating room time before incision, indicating that while they may be useful in a broader pain management strategy, they do not provide standalone benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. Wallace, CC., Wetzel, ME., Howell, C., et al.[2023]

The PECS type-1 block using 20 ml of 0.25% bupivacaine significantly reduces postoperative pain and fentanyl consumption after breast augmentation surgery compared to a control group, indicating its efficacy as an analgesic technique.

There was no significant difference in pain relief or fentanyl consumption between the 20 ml and 30 ml solution groups, suggesting that 20 ml is sufficient for effective analgesia, thus optimizing the use of anesthetic resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Different Volumes on Ultrasound-Guided Type-I Pectoral Nerve Block for Postoperative Analgesia After Subpectoral Breast Augmentation: A Prospective, Randomized, Controlled Study. Ekinci, M., Ciftci, B., Celik, EC., et al.[2020]

PECS blocks significantly reduce postoperative opioid use and pain scores for patients undergoing breast-conserving surgery compared to systemic analgesics, making them a recommended option for pain management in this context.

For mastectomy patients, PECS blocks offer an opioid-sparing effect comparable to paravertebral blocks, and are recommended for those who cannot receive a paravertebral block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Pectoralis Blocks in Breast Surgery: A Practice Advisory and Narrative Review from the Society for Ambulatory Anesthesia (SAMBA). Ardon, AE., George, JE., Gupta, K., et al.[2022]

The pectoral nerve (PECS) block significantly reduced postoperative pain levels and the need for propofol during breast cancer surgery, indicating its efficacy in pain management.

However, the PECS block did not improve the overall quality of recovery (QoR) scores on the first postoperative day, suggesting that while it helps with immediate pain relief, other factors may influence recovery that are not captured by pain scores alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. Kamiya, Y., Hasegawa, M., Yoshida, T., et al.[2022]

The Pecs II block significantly reduced postoperative morphine consumption by 3.67 mg and intraoperative fentanyl use in patients undergoing immediate breast reconstruction, indicating improved pain management compared to general anesthesia alone.

Patients receiving the Pecs II block experienced less postoperative nausea and vomiting and lower pain scores, with no reported complications from the block, highlighting its safety and efficacy in enhancing perioperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Ultrasound-guided Type II Pectoral Nerve Blocks in Perioperative Pain Management for Immediate Reconstruction After Modified Radical Mastectomy: A Prospective, Randomized Study. Wang, K., Zhang, X., Zhang, T., et al.[2022]

In a study of 53 patients undergoing bilateral reduction mammaplasty, tumescent anesthesia resulted in significantly lower postoperative antiemetic requirements compared to pectoral nerve block II (PECS II), indicating better management of nausea.

Tumescent anesthesia also led to shorter recovery times and lower overall hospitalization costs, making it a more favorable option for multimodal pain control in reduction mammaplasty patients compared to PECS II.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Tumescent Anesthesia Versus Pectoral Nerve Block in Bilateral Reduction Mammaplasty. McLaughlin, CM., Hughes, AJ., Lee, CC., et al.[2023]

A randomized controlled trial involving 34 patients undergoing bilateral mastectomy found that ultrasound-guided pectoralis muscle blocks (PECS I/II) performed either before or after surgery resulted in similar pain control outcomes, indicating that the timing of the block does not significantly affect postoperative pain management.

Both pre-incision and post-mastectomy blocks showed no significant differences in pain scores, narcotic requirements, or length of hospital stay, suggesting that either timing is effective for managing pain after mastectomy with reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Single-Blinded Study Comparing Preoperative with Post-Mastectomy PECS Block for Post-operative Pain Management in Bilateral Mastectomy with Immediate Reconstruction. Lizarraga, IM., Huang, K., Yalamuru, B., et al.[2023]

In a study of 159 female patients undergoing modified radical mastectomy, adding dexmedetomidine to bupivacaine significantly reduced postoperative morphine consumption and prolonged the time to first analgesic request compared to bupivacaine alone or with ketamine.

Patients who received dexmedetomidine with bupivacaine reported higher satisfaction levels, indicating that this combination may offer superior postoperative pain control without increasing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pecs-ⅠⅠ Block on Postoperative Pain Control in Patients Undergoing Breast Surgery. Hefni, AF., Eldeek, AM., Ismael, SA., et al.[2022]

The Pecs II block significantly reduced the need for intraoperative and postoperative analgesics in patients undergoing breast reduction surgery, with a notable decrease in total fentanyl consumption compared to the control group.

Patients receiving the Pecs II block reported lower postoperative pain levels (measured by VAS scores) and had shorter hospital stays, with no complications related to the block observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Sercan, O., Karaveli, A., Ozmen, S., et al.[2022]

A systematic review of 10 randomized controlled trials involving 502 patients found that pectoral (PECs) block and paravertebral block (PVB) provide comparable postoperative analgesia for mastectomy, with no significant differences in opioid consumption or time to first rescue analgesia.

The most common adverse event reported was postoperative nausea and vomiting, indicating that both techniques have similar safety profiles, and the choice between them should depend on the practitioner's expertise and institutional protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pectoral block versus paravertebral block: a systematic review, meta-analysis and trial sequential analysis. Jin, Z., Durrands, T., Li, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39896737/

Efficacy of pectoralis nerve blocks I & II with liposomal ... Patients receiving the PECS block had decreased outpatient narcotic requirements compared to those patients who did not get the block.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05171179

The Use of Pecs Blocks in Combination With Exparel ... This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S095281802400179X

Combined pectoralis and serratus anterior plane blocks ... Furthermore, there was no improvement in respiratory mechanics, no reduction in opioid consumption, and no decrease in pain scores. Thus, the data presented ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12069866/

Comparing the Efficacy of Preoperative Regional Nerve ... Our data suggests that intraoperative placement of Exparel PECS 1 and 2 blocks is effective for pain control and can minimize narcotic use.

5. trial.medpath.com trial.medpath.com/clinical-trial/77e235c288521226/nct05171179-prospective-randomized-trial-pecs-blocks-exparel-breast-reconstruction

The Use of Pecs Blocks in Combination With Exparel in Breast ... Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and ...

6. withpower.com withpower.com/trial/phase-3-9-2021-051de

Pecs Blocks + Exparel for Breast Reduction Surgery Pecs blocks are considered a safer alternative to other types of nerve blocks for breast surgery, and they have been shown to reduce the need for opioids after ...