Pain Management Blocks for Mastectomy in Breast Cancer

Overseen By Alicia Heelan, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Cincinnati

Must not be taking: Opioids

Disqualifiers: Pregnancy, Allergy to anesthetics, others

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

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

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you have a prescription for opioids for pain within 30 days before surgery, you might not be eligible unless you haven't filled or taken them, which will be decided on a case-by-case basis.

What data supports the effectiveness of this treatment for pain management in mastectomy for breast cancer?

Research shows that using pectoral nerve blocks (PECS) during breast cancer surgery can reduce the need for opioids, lower pain scores, and decrease nausea and vomiting after surgery compared to traditional opioid-based anesthesia. PECS blocks are recommended for their pain-relieving effects, especially when other nerve block options are not available. ^{1 2 3 4 5}

Is the Pecs II block safe for use in humans?

The Pecs II block, used for pain management in breast surgery, has been shown to reduce the need for opioids and decrease nausea and vomiting after surgery, suggesting it is generally safe for humans. ^{1 2 4 5 6}

How does the Preoperative Pecs II block treatment differ from other treatments for pain management in mastectomy?

The Preoperative Pecs II block is unique because it provides pain relief without the use of opioids, which can reduce the need for additional pain medication and decrease the risk of nausea and vomiting after surgery. This treatment involves a nerve block that targets specific nerves in the chest area, offering an alternative to traditional opioid-based pain management methods. ^{1 2 4 7 8}

What is the purpose of this trial?

The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

Eligibility Criteria

This trial is for breast cancer patients preparing for a total mastectomy. It's designed to compare pain management and local anesthesia methods post-surgery. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

I am having a mastectomy at UCMC due to breast cancer or a high risk of it.

Exclusion Criteria

Non-English speaking

Patients who are pregnant

Patients with an allergy to local anesthetics (Except: patients with allergies only to topical anesthetics may be included)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Preoperative Pecs II block administered by anesthesiologists with light sedation

Same day as surgery

1 visit (in-person)

Surgery and Intraoperative Care

Intraoperative Pecs Blocks with bupivacaine or Exparel administered during surgery

Day 0: Surgery

1 visit (in-person)

Postoperative Recovery

Monitoring of postoperative pain and opioid use, with hospital stay up to 7 days

7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and patient satisfaction

21 days

1-3 visits (in-person)

Treatment Details

Interventions

• Intraoperative Pecs II block (IOB) & superior AT (EX or BP)
• Preoperative Pecs II block (POB) & superior AT (EX or BP)

Trial Overview The study is testing two pain management approaches: one using Exparel with an intraoperative Pecs II block (IOB) and superior AT, the other using Bupivacain with a preoperative Pecs II block (POB) and superior AT.

Participant Groups

Group I: 1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB) Active Control 1 Intervention

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 30 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Group II: 2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX) Active Control 1 Intervention

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 20 cc of Exparel mixed with 10 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Group III: 3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP) Active Control 1 Intervention

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle with superior anesthetic as determined by stage I, after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Group IV: 4) Preoperative Pecs II block (POB) & superior AT (EX or BP) Active Control 1 Intervention

Preoperative Pecs II block to be administered by 1 of 6 acute pain specialized anesthesiologists in same day surgery. Patient will be lightly sedated with midazolam, at the discretion of the anesthesiologist. The pecs II block will be performed under ultrasound guidance using a 21-gauge, 80 mm length needle to administer the superior anesthetic as determined in stage I.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Findings from Research

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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

Opioid-free anesthesia for breast cancer surgery: A comparison of ultrasound guided paravertebral and pectoral nerve blocks. A randomized controlled trial. [2022]

2. 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]

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

Clinical analgesic efficacy of pectoral nerve block in patients undergoing breast cancer surgery: A systematic review and meta-analysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pectoral nerve block combined with general anesthesia for breast cancer surgery: a retrospective comparison. [2022]

5. 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]

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

Analgesic efficacy of the Pecs II block: a systematic review and meta-analysis. [2019]

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

Continuous Pectoral Nerve Block Compared With Continuous Thoracic Paravertebral Block and Intravenous Opioid Analgesia for the Postoperative Analgesic Efficacy in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Trial. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of ultrasound-guided pectoral nerve block versus thoracic paravertebral block using levobupivacaine and dexamethasone for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. [2022]