Nerve Interface for Post-Mastectomy Pain
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo mastectomy with immediate breast reconstruction surgery, with or without the RPNI procedure
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
What Are the Treatments Tested in This Trial?
Interventions
- Regenerative Peripheral Nerve Interface
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Kokosis
Lead Sponsor