Multi-Site Nerve Blocks for Post-Mastectomy Pain Management

Overseen By Emily Lin, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Memorial Sloan Kettering Cancer Center

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: 1

1507 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

Hanae Tokita, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to provide written informed consent

I agree to receive a nerve block.

I am having both breasts removed and reconstructed right away.

Exclusion Criteria

None applicable, as exclusion occurs prior to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Nerve Block Administration

Participants receive nerve blocks (PVB, Serratus+PECS-1, or PVB+PECS-1) before undergoing double mastectomy with immediate reconstruction

1 day

1 visit (in-person)

Postoperative Pain Management

Participants are monitored for pain management effectiveness and reduction in need for pain medication after surgery

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PECS-1
• PVB Protocol
• Serratus

Trial Overview 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.

How Is the Trial Designed?

Group I: Serratus + PECS-1 Experimental Treatment 2 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-1 Experimental Treatment 2 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: PVB Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+