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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to manage pain for women undergoing a double mastectomy with immediate reconstruction. Researchers aim to determine if injecting pain medicine at various sites can reduce the need for pain pills after surgery. The study compares three methods: a nerve block near the spine (PVB Protocol), another between chest muscles (PECS-1), and a third under the rib area (Serratus). Women undergoing this specific surgery and open to receiving nerve blocks might be suitable for the trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research shows that the treatments in this study are generally well-tolerated.

For the PECS-1 block, studies have found it safe and effective for reducing pain after a mastectomy. Patients reported less pain, and no major side effects occurred.

The PVB (paravertebral block) is also considered safe. Evidence indicates it provides good pain relief with few side effects.

The Serratus block offers excellent pain relief. It is less invasive, which usually means fewer risks.

Overall, these treatments have been well-studied and are considered safe with minimal side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores innovative nerve block techniques to manage post-mastectomy pain, potentially offering quicker and more effective relief compared to traditional pain medications like opioids. The trial includes three different methods: PVB + PECS-1, Serratus + PECS-1, and PVB alone. Each technique involves precise ultrasound-guided injections to target specific nerve areas, which could result in better pain control with fewer side effects. By comparing these approaches, the trial aims to identify the most effective method for reducing pain and improving recovery after surgery.

What evidence suggests that this trial's treatments could be effective for post-mastectomy pain management?

Research has shown that certain nerve blocks can reduce pain after breast surgery. In this trial, participants may receive different combinations of these nerve blocks. The PECS-1 block, which some participants will receive, has lowered pain levels and reduced the need for opioid painkillers after surgery. Other participants will receive the paravertebral block (PVB), which studies indicate provides early pain relief and reduces long-term pain. The serratus block, another option in this trial, has effectively decreased both immediate pain and nausea after surgery. Overall, these nerve blocks can better manage pain and may reduce medication use after a mastectomy. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7076325/

Pectoral Nerve (PECs) block for postoperative analgesia-a ... Conclusion: When compared to general anesthesia with systemic opioids, PECs block was associated with significantly better perioperative pain control. There are ...

2. rapm.bmj.com rapm.bmj.com/content/50/Suppl_1/A142.1

EP159 PECS I-II vs. ESP blocks for chronic post ... This study aimed to compare the effects of preoperative PECS I-II and ESP blocks on acute pain control, opioid requirements, and CPMP incidence at 3 months.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39688831

Pectoralis I and Serratus Anterior Plane Block Analgesia ... The PECS I/SAP block may potentially reduce pain in patients having breast surgery for cancer by providing analgesia to the lateral and anterior chest wall.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/04030/clinical_analgesic_efficacy_of_pectoral_nerve.32.aspx

Clinical analgesic efficacy of pectoral nerve block in... Our meta-analysis showed that the use of Pecs block significantly reduced VAS pain scores up to 24 hours postoperatively.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587821000966

“Post Mastectomy Pain Syndrome: A Systematic Review of ... Three studies with a total of 403 patients investigated the utility of pectoral nerve blocks (PECS) in preventing chronic pain after breast cancer-related ...

6. nature.com nature.com/articles/s41598-023-31589-6

One year follow-up on a randomized study investigating ... The results showed that the use of SAM + PECS I with general anesthesia reduced numbness, hypoesthesia to touch, the incidence of patients with ...

7. 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 ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04016376

Study of Nerve Block Pain Management in Patients ... The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with ...