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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 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
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.

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,963 Previous Clinical Trials
595,889 Total Patients Enrolled
206 Trials studying Breast Cancer
82,492 Patients Enrolled for Breast Cancer
Hanae Tokita, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

PVB Protocol Clinical Trial Eligibility Overview. Trial Name: NCT04016376 — Phase 4
Breast Cancer Research Study Groups: PVB + PECS-1, Serratus + PECS-1, PVB
Breast Cancer Clinical Trial 2023: PVB Protocol Highlights & Side Effects. Trial Name: NCT04016376 — Phase 4
PVB Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04016376 — Phase 4
~170 spots leftby Jul 2025