Pecs Blocks + Exparel for Breast Reduction Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Robert Galiano, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Northwestern University

Disqualifiers: Flap surgery, Radiation therapy, Pregnancy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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

Trial 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) (Procedure)
• Bupivacaine (Local Anesthetic)
• Exparel (Non-opioid Analgesic)
• Lidocaine (Local Anesthetic)
• Pecs blocks (Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern Memorial Hospital Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1674

Patients Recruited

989,000+

Pacira Pharmaceuticals, Inc

Industry Sponsor

Trials

142

Patients Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]