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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.

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.

What data supports the effectiveness of this treatment for breast reduction surgery?

Research shows that Pecs blocks can reduce opioid use and pain after breast surgeries like mastectomies, and they may have similar benefits for breast reduction surgeries. However, their effectiveness specifically for breast reductions is still being studied. ^{1 2 3 4 5}

Is the combination of Pecs blocks and Exparel generally safe for use in humans?

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 surgery, which suggests a favorable safety profile. ^{1 5 6 7 8}

How does the treatment Pecs Blocks + Exparel for breast reduction surgery differ from other treatments?

Pecs Blocks combined with Exparel for breast reduction surgery is unique because it uses a nerve block technique to manage pain, potentially reducing the need for opioids. This approach is different from traditional pain management methods, which often rely on systemic analgesics or local infiltration anesthesia. ^{1 5 7 9 10}

Research Team

Robert Galiano, MD

Principal Investigator

3126956022

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Intravenous lidocaine Experimental Treatment 2 Interventions

Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)

Group II: 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 and in ability to use lidocaine infusion with injection of Exparel)

Group III: 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

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. [2023]

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

Comparison of Tumescent Anesthesia Versus Pectoral Nerve Block in Bilateral Reduction Mammaplasty. [2023]

3. United States 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. [2023]

4. Turkey 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. [2022]

5. United States 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). [2022]

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

Pectoral block versus paravertebral block: a systematic review, meta-analysis and trial sequential analysis. [2022]

7. England 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. [2022]

8. United States 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. [2022]

9. United States 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. [2020]

10. United States 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. [2022]