Nerve Interface for Post-Mastectomy Pain

RA
Overseen ByResearch Administrator
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: George Kokosis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to reduce nerve pain after breast cancer surgery. It uses a technique called Regenerative Peripheral Nerve Interface (RPNI), which protects nerves with a piece of muscle during surgery to prevent long-term pain, such as discomfort and tingling. The trial seeks women undergoing a mastectomy with immediate reconstruction who are willing to participate in follow-up surveys about their pain and quality of life. Participants will be randomly assigned to either receive the RPNI procedure or not, and researchers will track their progress for about a year. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve post-surgical outcomes for future patients.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the study team.

What prior data suggests that this nerve interface is safe for post-mastectomy pain relief?

Research has shown that the Regenerative Peripheral Nerve Interface (RPNI) is safe to use. In one study, patients who underwent RPNI for chronic pain after a mastectomy reported a significant reduction in pain levels post-surgery. Another study found that using RPNI during major limb amputation reduced pain and decreased the need for opioids, which are strong painkillers with potential side effects.

RPNI surgery is considered safe, simple, and effective for various types of surgeries. It involves using a small piece of the patient's own muscle to protect nerves, which can help prevent or lessen nerve pain. Overall, patients have tolerated RPNI well, and it shows promise in managing pain without major side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Regenerative Peripheral Nerve Interface (RPNI) for post-mastectomy pain because it offers a new approach to managing nerve pain after breast cancer surgery. Unlike standard treatments like pain medications or nerve blocks, RPNI aims to directly interface with peripheral nerves to potentially reduce pain more effectively. This technique involves connecting a small piece of muscle to the severed nerve endings, which may help prevent painful neuroma formation and improve quality of life. By targeting the source of pain at the nerve level, it holds promise for providing longer-lasting relief than conventional methods.

What evidence suggests that the regenerative peripheral nerve interface is effective for preventing post-breast surgery pain?

Research has shown that the Regenerative Peripheral Nerve Interface (RPNI), which participants in this trial may receive, can greatly reduce pain for individuals experiencing post-mastectomy pain. In one study, patients reported their pain levels dropping from a 9 to a 1 after receiving RPNI treatment. Another study found that those treated with RPNI experienced fewer nerve pain symptoms. These findings suggest that RPNI may help prevent and reduce long-term nerve pain after breast cancer surgery.16789

Who Is on the Research Team?

GK

George Kokosis, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adult females aged 18-65 who are planning to have a mastectomy with immediate breast reconstruction. Participants must be willing to complete surveys about their pain and quality of life before and after surgery.

Inclusion Criteria

Able to provide informed consent and comply with study procedures
I am a woman aged between 18 and 65.
I am having a breast removal with immediate reconstruction.

Exclusion Criteria

Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments
Unwillingness or inability to comply with the study's follow-up requirements
I have a long-term pain condition not related to breast surgery.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mastectomy with immediate breast reconstruction surgery, with or without the RPNI procedure

1 day
1 visit (in-person)

Follow-up

Participants complete self-reported surveys at Months 1, 3, 6, and 12 post-surgery to measure pain levels, quality of life, and function

12 months
4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Regenerative Peripheral Nerve Interface
Trial Overview The study tests if the RPNI procedure, which involves protecting nerves with muscle tissue during mastectomy, can prevent or reduce long-term nerve pain compared to standard surgery. Patients will be randomly assigned to either receive RPNI or not.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: RPNIExperimental Treatment1 Intervention
Group II: No RPNI (Control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Kokosis

Lead Sponsor

Trials
1
Recruited
200+

Published Research Related to This Trial

The study assessed the biocompatibility of the transverse intrafascicular multi-channel electrode (TIME) by implanting it in the median nerves of Göttingen minipigs for 33-38 days, showing no significant inflammatory response or necrosis, indicating good safety.
The presence of only a layer of fibrosis around the implant suggests that the TIME could be a promising neural interface for future use in neuroprostheses, as it demonstrates favorable biosafety characteristics.
Biosafety assessment of an intra-neural electrode (TIME) following sub-chronic implantation in the median nerve of Göttingen minipigs.Kundu, A., Wirenfeldt, M., Harreby, KR., et al.[2017]
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.
Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain.Kubiak, CA., Kemp, SWP., Cederna, PS., et al.[2022]

Citations

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 ...
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 ...
Prophylactic Intercostal Regenerative Peripheral Nerve ...Median follow-up period was 19.0 months. CONCLUSION: We report a low rate of intercostal neuroma-related PBPSPS after treatment with prophylactic intercostal ...
Regenerative Peripheral Nerve Interface Surgery for the ...Clinical studies in human patients have also demonstrated improved pain outcomes following RPNI surgery ( Fig. 2 ). In single-cohort retrospective studies, ...
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 ...
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 ...
Regenerative Peripheral Nerve Interface (RPNI) for the...Conclusion: Prophylactic RPNI at the time of major limb amputation for oncology patients is associated with a substantial reduction in pain and opioid use.
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.
Regenerative Peripheral Nerve Interface Surgery: Anatomic ...Regenerative peripheral nerve interface surgery is safe, straightforward, reproducible, reliable, effective, and scalable to many surgical specialties.
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