Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve I… (NCT04530526) | Clinical Trial Compass
CompletedNot Applicable
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
United States26 participantsStarted 2019-07-12
Plain-language summary
Post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life. The investigators on this study will evaluate the regenerative peripheral nerve interface (RPNI), a novel surgical approach to neuroma treatment, to improve patient-reported post-mastectomy pain and definitively treat intercostal neuromas after mastectomy.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Reporting post-mastectomy pain at least six months removed from mastectomy or partial mastectomy (lumpectomy).
* Willing to comply with all study procedures and be available for the duration of the study
* Fluent in English
* Women of reproductive potential must use highly effective contraception (specify methods of contraception acceptable for the study, e.g., licensed hormonal methods) and/or willingness to undergo a pregnancy test.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Previous surgical management for chronic post-mastectomy pain
* Signs/symptoms which are not suggestive of neuropathic pain based on physical exam at time of consultation.
* Pregnancy or lactation
* Men will not be enrolled in this study due to the low prevalence of male mastectomy.
* Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Level
Timeframe: baseline, and 9 months post surgery
2
Change in Depression/Anxiety Scores
Timeframe: baseline, and 9 months post surgery
3
Change in Opioid Consumption (Number of Opioid Medications)
Timeframe: baseline, and 9 months post surgery
4
Freedom From Neuroma Recurrence Evaluated by Physical Exam
Timeframe: 24 months post enrollment
5
Freedom From Neuroma Recurrence Evaluated by Ultrasound
Timeframe: 24 months post enrollment
6
Change in Opioid Consumption (Oral Morphine Equivalents)