What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, radiation therapy, and surgical interventions, often have a range of side effects. Chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and localized pain. Surgical interventions, such as mastectomy, can result in pain, swelling, and limited range of motion. Nerve blocks, like ultrasound-guided paravertebral and serratus plane blocks, used for pain management, are generally safe but can have side effects such as temporary numbness, infection at the injection site, and, rarely, nerve damage.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including chemotherapy, hormone therapy, targeted therapy, and immunotherapy. While nerve blocks or regional anesthesia are not typically primary treatments for breast cancer, they are used as supportive measures to manage pain, particularly post-surgery. For instance, ultrasound-guided nerve blocks have been shown to be effective in reducing pain and opioid consumption after breast surgeries, including mastectomies. These interventions are part of a broader pain management strategy to improve patient comfort and recovery.

What other types of research exist?

Promising novel alternatives to nerve block for breast cancer patients include: 1) Non-invasive ventilation during surgery under neuraxial anesthesia, which has shown benefits in reducing perioperative morbidity. 2) The use of adjuvant analgesics such as gabapentin or pregabalin, which have been effective in managing neuropathic pain. 3) Emerging therapies like ketamine and lidocaine infusions, which are being explored for their potential in chronic pain management. 4) Topical treatments like lidocaine patches, which provide localized pain relief without systemic side effects.

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Multi-Site Nerve Blocks for Post-Mastectomy Pain Management

Phase 4

Waitlist Available

Led By Hanae Tokita, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing Bilateral Mastectomy with immediate reconstruction (BMw/IR)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if giving pain-relief injections at certain spots before a double mastectomy and reconstruction can reduce the need for pain medication afterward. The injections work by numbing the nerves to block pain signals. The study focuses on patients undergoing this specific surgery to see if they can experience less pain post-operation.

Who is the study for?

This trial is for English-speaking women aged 18 or older who are scheduled for a double mastectomy with immediate reconstruction at the Josie Robertson Surgical Center. Participants must be suitable and agree to receive a nerve block, which is an injection used to manage pain.

What is being tested?

The study is testing different sites of nerve block injections (PVB Protocol, Serratus, PECS-1) before surgery to see if they can reduce the need for pain medication after undergoing a double mastectomy with immediate tissue expander reconstruction.

What are the potential side effects?

While specific side effects are not listed here, common side effects of nerve blocks may include discomfort at the injection site, weakness or numbness in certain muscles temporarily, and less commonly bruising or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having both breasts removed and reconstructed right away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Serratus + PECS-1Experimental Treatment2 Interventions

For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor. For the serratus block, the patient will be placed in the supine or lateral decubitus position and with an ultrasound probe, in the parasagittal plane, the serratus muscles will be identified. Injections will be done in-plane below the serratus anterior.

Group II: PVB + PECS-1Experimental Treatment2 Interventions

Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes. For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor.

Group III: PVBExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments primarily include systemic therapies like chemotherapy, which targets rapidly dividing cancer cells; hormone therapy, which blocks hormones that fuel certain types of breast cancer; and targeted therapy, which attacks specific molecules involved in cancer growth. Local treatments include surgery to remove tumors and radiation to destroy cancer cells in a specific area. Nerve blocks, a form of regional anesthesia, are used to manage pain by interrupting pain signals from reaching the brain. This is particularly important for breast cancer patients undergoing surgeries like mastectomies, as effective pain management can significantly improve recovery and quality of life.