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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 30 days from study treatment

Awards & highlights

Study Summary

This trial will test whether using more than one site for pain medication injections before a double mastectomy reduces post-operative pain medication needs.

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.Check my eligibility

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.See study design

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 ~ 30 days from study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days from study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days from study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare preoperative nerve blocks between a combination of nerve blocks and PVB alone to decrease postoperative opioid consumption

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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

584,115 Total Patients Enrolled

202 Trials studying Breast Cancer

79,630 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients is this clinical trial accommodating?

"Affirmative. Based on the information available at clinicaltrials.gov, this study is currently recruiting patients. The trial went live on July 5th 2019 and was updated as recently as November 18th 2022 - with a target of 1500 participants to be enrolled from one location."

Answered by AI

Is this research recruiting new participants?

"Correct. According to the details hosted on clinicaltrials.gov, this medical study, which was originally published on July 5th 2019, is currently in search of participants. Approximately 1,500 patients need to be recruited from one centre for participation."

Answered by AI

Does the PVB Protocol pose any risks for study participants?

"Confident in the safety of PVB Protocol, our team at Power ascribed a score of 3 to this treatment which has been approved by Phase 4 clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction

2019. "Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04016376.