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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares different methods for managing pain in breast cancer patients undergoing a full mastectomy. Researchers aim to evaluate how two types of pain relief methods, including special numbing injections known as Pecs Blocks, perform during surgery (Intraoperative Pecs II block) and before surgery (Preoperative Pecs II block). The goal is to identify the best approach to keep patients comfortable. Women undergoing a full mastectomy for breast cancer or at high risk for it, such as those with certain genetic mutations or a strong family history, might be eligible to participate. As a Phase 4 trial, this study involves treatments that are already FDA-approved and proven effective, seeking to understand how they can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that Pecs II blocks, whether performed during or before surgery, are generally well-tolerated. Studies indicate that these blocks help patients recover faster and experience fewer complications after surgery. They are safe and effective in reducing pain during and after a mastectomy.

For Pecs II blocks done during surgery, patients recover quickly and face fewer issues afterward. This type of block also reduces the risk of long-term pain after surgery.

Similarly, Pecs II blocks performed before surgery significantly lessen chronic pain at the surgery site and lower the risk of long-term pain problems after breast surgery.

Both methods use local anesthesia, which is safe and carries minimal risk of side effects. Overall, these blocks appear to be a reliable option for managing pain in breast cancer surgery, with studies supporting their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it's exploring innovative ways to manage pain after a mastectomy. Unlike standard treatments that primarily rely on systemic opioids, which can have significant side effects, these techniques focus on localized pain relief through Pecs II blocks. This method uses direct visualization and precision injections of anesthetics like bupivacaine and Exparel, either preoperatively or intraoperatively, allowing for potentially more effective and targeted pain control. By minimizing systemic medication use, these methods might reduce side effects and improve recovery experiences for patients.

What evidence suggests that this trial's treatments could be effective for pain management in breast cancer mastectomy?

This trial will compare different timing and formulations of Pecs II blocks for pain management in breast surgery. Research has shown that using Pecs II blocks before and during breast surgery helps manage postoperative pain. Studies indicate that the Pecs II block can significantly reduce pain for up to 24 hours after surgery and decrease the need for opioids, which are addictive pain-relief drugs. One study found that using the Pecs II block during surgery may help prevent long-term pain three months later. Overall, this method appears promising for reducing discomfort after surgery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9986367/

Postoperative Analgesic Efficacy of Intraoperative Pectoral ... Recent studies have shown that the PECs II block can prevent chronic pain 3 months after breast surgery [20]. Few scholars have focused on the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06574022

Study Details | NCT06574022 | Post-mastectomy Recovery ... The purpose this research is to compare two different standards of care for pain management and two different standards of care for local ...

3. ait-journal.com ait-journal.com/Efficacy-of-type-I-and-type-II-pectoral-nerve-blocks-PECS-I-and-II-in-patients-undergoing,152278,0,2.html

Efficacy of type-I and type-II pectoral nerve blocks (PECS I and ... PECS I/II blockade with high-dose local anaesthetic is efficacious and safe, resulting in lower levels of perioperative pain after mastectomy ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10608528/

Evaluation of the Efficacy of Pectoral Nerve-2 Block (PECS ... This study aimed to evaluate the efficacy of the pectoral nerves interfacial plane block (PECS II) in breast cancer surgery focusing on postoperative pain ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S095281801630575X

Prospective double blind randomized placebo-controlled ... The Pecs block type II results in lower pain levels and reduces postsurgical opioid consumption during the PACU stay time for patients undergoing breast surgery ...

6. epain.org epain.org/journal/view.html?doi=10.3344/kjp.2019.32.4.286

PECS II block is associated with lower incidence of chronic ... In conclusion, our study suggests that the PECS II block could be able to prevent chronic pain after breast surgery at 3 months after surgery.

7. medrxiv.org medrxiv.org/content/10.1101/19006924v1.full-text

Does Pecs II Block Reduce the Incidence of Post ... Furthermore, Pecs II group reported significantly lower Chronic Pain Symptom and Sign Score (P = 0.002) compared to conventional group.