Nerve Interface Surgery for Pain After Breast Reconstruction

Recruiting at 6 trial locations

Overseen By Babak Mahrara, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Exchange surgery, Active pain, 15 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the prevalence of ongoing pain after breast reconstruction surgery and to test a new procedure called Regenerative Peripheral Nerve Interface (RPNI) to reduce this pain. RPNI surgery reconnects nerves to alleviate neuropathic pain following a mastectomy. Women who have undergone breast cancer surgery with reconstruction and continue to experience pain six months later may be suitable for this study. Participants should have had their surgery at Memorial Sloan Kettering (MSK) and not undergone any recent revision surgeries. As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research that could enhance pain management after breast reconstruction.

Will I have to stop taking my current medications?

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 prior data suggests that Regenerative Peripheral Nerve Interface (RPNI) Surgery is safe for reducing pain after breast reconstruction?

Studies have shown that Regenerative Peripheral Nerve Interface (RPNI) surgery is generally safe and well-tolerated. Research indicates that the surgery is straightforward and reliable, yielding positive outcomes for patients. In one study involving seven patients who received RPNI for chronic pain after a mastectomy, pain levels significantly dropped. This finding suggests that the procedure not only reduces pain but is also manageable for patients.

Additionally, experts report that RPNI surgery can be effectively used in various types of surgeries, demonstrating its adaptability and safety. So far, no major unwanted side effects have been reported, making it a promising option for those experiencing pain after breast reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Regenerative Peripheral Nerve Interface (RPNI) Surgery is unique because it offers a new approach to managing pain after breast reconstruction by focusing on nerve repair and regeneration. Unlike traditional pain management methods, which often rely on medications like opioids or nerve blocks to mask pain, RPNI Surgery works by reconnecting severed nerves to small muscle grafts, thus promoting natural nerve healing and reducing pain at its source. Researchers are excited about this technique because it has the potential to provide long-term relief without the side effects associated with long-term medication use, representing a significant advancement in post-surgical pain management.

What evidence suggests that RPNI surgery is effective for reducing pain after breast reconstruction?

Research has shown that a type of surgery called Regenerative Peripheral Nerve Interface (RPNI) can greatly reduce pain for individuals experiencing ongoing pain after a mastectomy. In one study, patients who underwent RPNI surgery reported their pain dropping from a high level of 9 to just 1. Another study suggested that RPNI surgery might help prevent pain after breast cancer surgery by targeting the involved nerves. Although more research is needed due to the small number of participants in these studies, these early results offer hope for those dealing with long-term pain after breast reconstruction. Participants in this trial will undergo RPNI surgery to evaluate its effectiveness in reducing postmastectomy pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Danielle Rochlin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This study is for individuals who have undergone a mastectomy and breast reconstruction surgery due to breast cancer and are experiencing persistent pain after the procedures. Specific details on eligibility criteria were not provided.

Inclusion Criteria

I am female.

I have had breast reconstruction using implants or my own tissue.

I have had a mastectomy due to breast cancer or have a genetic risk for it.

Exclusion Criteria

I have not had surgery to replace or fix a medical device within the last 6 months.

I have pain due to an infection, cancer, or a wound.

It has been over 15 years since my reconstruction surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo regenerative peripheral nerve interface (RPNI) surgery to reduce neuropathic pain after breast reconstruction

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Regenerative Peripheral Nerve Interface (RPNI) Surgery

Trial Overview The trial aims to assess how common postmastectomy pain is and evaluate the effectiveness of regenerative peripheral nerve interface (RPNI) surgery in reducing neuropathic pain following breast reconstruction.

How Is the Trial Designed?

Group I: Postmastectomy Reconstruction Participants Experimental Treatment 4 Interventions

Participants will be postmastectomy reconstruction and \>/= 6 months postoperative

Regenerative Peripheral Nerve Interface (RPNI) Surgery is already approved in United States, European Union for the following indications:

Approved in United States as RPNI Surgery for:

• Post-amputation phantom limb pain
• Neuroma pain
• Post-mastectomy pain syndrome

Approved in European Union as RPNI Surgery for:

• Post-amputation phantom limb pain
• Neuroma pain
• Post-mastectomy pain syndrome

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 28 diabetic amputees, those who underwent regenerative peripheral nerve interface (RPNI) surgery experienced a significant reduction in pain, with all patients in the RPNI group reporting no pain compared to 78.6% of the control group experiencing severe pain.

RPNI not only effectively managed post-amputation pain and reduced the risk of neuroma formation, but it also allowed patients to use prosthetics significantly more, without increasing operative time or complications, suggesting it is a safe and beneficial surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Regenerative Peripheral Nerve Interfaces in Elective Lower Limb Amputations. Pejkova, S., Nikolovska, B., Srbov, B., et al.[2022]

In a study involving 16 amputees who received regenerative peripheral nerve interfaces (RPNIs) for symptomatic neuromas, patients reported a significant 71% reduction in neuroma pain and a 53% reduction in phantom pain after surgery.

The RPNI procedure demonstrated a favorable safety profile, with 75% of patients expressing satisfaction with the treatment and a high likelihood of recommending it to others, indicating its efficacy as a treatment option for neuroma relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Woo, SL., Kung, TA., Brown, DL., et al.[2022]

The Regenerative Peripheral Nerve Interface (RPNI) is a novel surgical technique that uses an autologous muscle graft to prevent the formation of symptomatic neuromas after limb amputation, addressing a common source of pain and discomfort for amputees.

Clinical and animal studies have shown that RPNI is a safe and effective method for treating and preventing neuroma formation, which can improve outcomes for patients with major limb amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Decreasing Postamputation Pain with the Regenerative Peripheral Nerve Interface (RPNI)". Kubiak, CA., Adidharma, W., Kung, TA., et al.[2022]

In a study of 90 patients, those who received prophylactic regenerative peripheral nerve interfaces during limb amputation had a significantly lower incidence of symptomatic neuromas (0.0%) compared to control patients (13.3%).

Patients with the nerve interfaces also reported much less phantom limb pain (51.1%) compared to control patients (91.1%), indicating that these interfaces may help prevent pain by reducing neuroma formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. Kubiak, CA., Kemp, SWP., Cederna, PS., et al.[2022]

Prophylactic Regenerative Peripheral Nerve Interface (RPNI) effectively prevents neuroma pain in both male and female rats, indicating its potential as a pain management strategy.

However, the study found that female rats experienced a delay in pain relief compared to males, with specific types of pain (cold and thermal allodynia) being alleviated only in males, suggesting sex-specific differences in pain response and underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexually Dimorphic Pattern of Pain Mitigation Following Prophylactic Regenerative Peripheral Nerve Interface (RPNI) in a Rat Neuroma Model. Dehdashtian, A., Timek, JH., Svientek, SR., et al.[2023]

Regenerative peripheral nerve interfaces (RPNIs) successfully recorded myoelectric signals during walking in rats, demonstrating their potential for controlling prosthetic devices with over 80% reliability in predicting ankle motion.

The study showed minimal signal contamination from adjacent muscles, indicating that RPNIs can effectively encode neural activation patterns related to gait, which is crucial for their use in prosthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo characterization of regenerative peripheral nerve interface function. Ursu, DC., Urbanchek, MG., Nedic, A., et al.[2017]

Regenerative Peripheral Nerve Interfaces (RPNIs) in a rodent model showed that adjacent RPNIs, neurotized by different nerves, can produce independent electromyographic signals during walking, indicating their potential for effective motorized prosthesis control.

The study found that the electromyographic activity from RPNIs was similar to that of control muscles, suggesting minimal crosstalk and confirming that RPNIs can encode distinct neural activation patterns associated with gait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjacent regenerative peripheral nerve interfaces produce phase-antagonist signals during voluntary walking in rats. Ursu, D., Nedic, A., Urbanchek, M., et al.[2020]

In a study using rat models, smaller regenerative peripheral nerve interfaces (RPNIs) constructed with 150 and 300 mg muscle grafts showed significantly better electrical signaling and muscle force compared to larger grafts of 600 and 1200 mg.

Larger RPNIs exhibited areas without regenerated muscle fibers, indicating that smaller grafts are more effective for maintaining tissue viability and enhancing neuroprosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative peripheral nerve interface free muscle graft mass and function. Hu, Y., Ursu, DC., Sohasky, RA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12201984/

Intercostal Regenerative Peripheral Nerve Interface for the ... One study of 7 patients receiving RPNI for chronic postmastectomy-related pain reported a decrease in median pain scores from 9 preoperatively to 1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04530526

Surgical Treatment of Post-surgical Mastectomy Pain ... Using patient-reported outcomes and clinical data the investigators will evaluate the use of RPNI surgery to reduce persistent post- mastectomy pain in women ...

3. ps-rc.org ps-rc.org/meeting/program/2025/203.cgi

Prophylactic Intercostal Regenerative Peripheral Nerve ... Our findings suggest that intercostal nerve RPNI may decrease the rate of PBSPS. However, since our sample size is small, further study is required to determine ...

4. journals.lww.com journals.lww.com/aosopen/fulltext/2025/03000/regenerative_peripheral_nerve_interface_surgery_to.6.aspx

Regenerative Peripheral Nerve Interface Surgery to Treat... RPNI surgery significantly improved residual limb pain. While phantom limb sensation improved significantly, phantom limb pain demonstrated a modest decrease.

5. springermedicine.com springermedicine.com/mastectomy/breast-cancer/use-of-prophylactic-regenerative-peripheral-nerve-interface-for-/51312386

Use of prophylactic regenerative peripheral nerve interface ... Conclusions. Our findings suggest RPNI could be a powerful tool for the prevention of pain in breast cancer patients following mastectomy.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06580951

Regenerative Peripheral Nerve Interface for Prophylaxis ... This single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory ...

7. academic.oup.com academic.oup.com/asjopenforum/article/doi/10.1093/asjof/ojaf037/8124405

Intercostal Regenerative Peripheral Nerve Interface for the ... One study of 7 patients receiving RPNI for chronic postmastectomy-related pain reported a decrease in median pain scores from 9 preoperatively ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10351954/

Regenerative Peripheral Nerve Interface Surgery: Anatomic ... Regenerative peripheral nerve interface surgery is safe, straightforward, reproducible, reliable, effective, and scalable to many surgical specialties.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-00371

Evaluating Regenerative Peripheral Nerve Interface ... This study collects information on reported pain before and after undergoing a type of nerve surgery called regenerative peripheral nerve interface (RPNI).