Post-mastectomy Pain SyndromeNCT06580951
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
A study testing Regenerative Peripheral Nerve Interface in people with Post-mastectomy Pain Syndrome, run by George Kokosis.
Trial summary
Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- Regenerative Peripheral Nerve Interface
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female 18 to 65 years of age.
- Undergoing breast mastectomy with immediate reconstruction.
- Able to provide informed consent and comply with study procedures.
Who cannot join
- History of chronic pain syndrome unrelated to breast surgery.
- Unwillingness or inability to comply with the study's follow-up requirements.
- Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.
- Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.
- Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain
Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the decade that followed, it was found RPNI surgery not only provided amputees with neuroma (a growth made up nerve tissue) pain relief but could help prevent neuroma from developing as well.
This single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory nerves with a small piece of the patient's pectoralis muscle, performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent and/or reduce the risk for long-term nerve pain after breast cancer surgery (also called neuroma-related post-breast surgery pain syndrome (PBSPS)) versus the standard surgery alone (Control group). Symptoms of PBSPS include discomfort, numbness, tingling, and shooting pain in the chest and breast area. It is relatively common and may have many causes.
About 200 adult females (18-65 years old) who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study. Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Study participants will complete self-reported surveys (pre-surgery and at Months 1, 3, 6, and 12 post-surgery) designed to measure pain levels, quality of life, and function before and after surgery. Study participation will last approximately 12 months. Subjects will remain blinded to their assigned study arm until their study participation has concluded.
- Conditions
- Post-mastectomy Pain Syndrome
- Being tested
- Regenerative Peripheral Nerve Interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Peripheral Nerve InterfaceProcedure or surgery
The RPNI portion of the case will consist of blunt dissection of the cut sensory branches of the intercostal nerves at the T3 and/or T4 levels, with creation of a peripheral nerve interface using a small cuff of dissected pectoralis muscle and 3-0 Monocryl suture. The breast reconstruction will otherwise be performed as per standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| RPNI | Experimental | Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects will in the RPNI arm will undergo mastectomy with breast reconstruction surgery with regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records. Receives: Procedure: Regenerative Peripheral Nerve Interface |
| No RPNI (Control) | No intervention | Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects undergo mastectomy with breast reconstruction surgery without regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neuroma-related PBSPS
The study's primary endpoint will be the incidence of neuroma-related PBSPS, assessed by comparing the proportion of participants in each group who experience this condition during a follow-up period of 12 months, through review of electronic medical records.
Measured: 12 months
Secondary outcomes (3)
Quality of Life change
This endpoint will be evaluated through use of the Breast-Q questionnaires.The Breast-Q questionnaire is a type of standardized patient-reported outcomes form. There is no overall or total BREAST-Q score, only scores for each independent scale. All BREAST-Q scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q scales, a higher score means greater satisfaction or better QOL (depending on the scale). If missing data is less than 50% of the scale's items, study team will use the mean of the completed items. Study team will convert the raw summed scale score into a score from 0 (worst) to 100 (best).
Measured: 12 months
Safety and Adverse Events
The electronic medical record will be reviewed and any safety or adverse events adjudicated and recorded.
Measured: 12 months
Pain change
Pain Distribution is a peer-reviewed survey that provides a visual reference of various pain distributions of common pathologies affecting the breast, chest, back, and upper extremities, including neuroma-related breast pain, which will allow delineation of the specific etiology causing the patient's pain. For each of the regions surveyed (Underneath Breast, Axilla/Armpit, Radiatin from Chest to Arm, Upper Outer Shoulder, Anterior Shoulder and Axilla/Armpit, Posterior Neck and Shoulder, Posterior Neck Radiating to Arm, Shoulder Blade/Scapula) subjects indicate pain severity and frequency. There is no overall score for the entire survey. The pain severity scale ranges from 0-10. Zero (0) indicates no pain (best), and 10 (ten) indicates the worst pain imaginable (worst). The pain frequency scale ranges from <1 day/week (best) to 7 days/week (worst).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Kokosis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, George Kokosis, Rush University Medical Center
- Investigators
- George Kokosis, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580951
- Sponsor's protocol ID
- 24042301
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain
- ClinicalTrials.gov ID
- NCT06580951
- Acronym / sponsor ID
- 24042301
- Conditions
- Post-mastectomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- George KokosisUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the decade that followed, it was found RPNI surgery not only provided amputees with neuroma (a growth made up nerve tissue) pain relief but could help prevent neuroma from developing as well.
This single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory nerves with a small piece of the patient's pectoralis muscle, performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent and/or reduce the risk for long-term nerve pain after breast cancer surgery (also called neuroma-related post-breast surgery pain syndrome (PBSPS)) versus the standard surgery alone (Control group). Symptoms of PBSPS include discomfort, numbness, tingling, and shooting pain in the chest and breast area. It is relatively common and may have many causes.
About 200 adult females (18-65 years old) who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study. Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Study participants will complete self-reported surveys (pre-surgery and at Months 1, 3, 6, and 12 post-surgery) designed to measure pain levels, quality of life, and function before and after surgery. Study participation will last approximately 12 months. Subjects will remain blinded to their assigned study arm until their study participation has concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPNI | Experimental | Procedure: Regenerative Peripheral Nerve InterfaceSubjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects will in the RPNI arm will undergo mastectomy with breast reconstruction surgery with regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records. |
| No RPNI (Control) | No intervention | –Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects undergo mastectomy with breast reconstruction surgery without regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult female 18 to 65 years of age.
- Undergoing breast mastectomy with immediate reconstruction.
- Able to provide informed consent and comply with study procedures.
Key exclusion criteria (5 listed)
- History of chronic pain syndrome unrelated to breast surgery.
- Unwillingness or inability to comply with the study's follow-up requirements.
- Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.
- Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.
- Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative Peripheral Nerve InterfaceThe RPNI portion of the case will consist of blunt dissection of the cut sensory branches of the intercostal nerves at the T3 and/or T4 levels, with creation of a peripheral nerve interface using a small cuff of dissected pectoralis muscle and 3-0 Monocryl suture. The breast reconstruction will otherwise be performed as per standard protocol. | Procedure or surgery | RPNI |
Primary outcome
Incidence of neuroma-related PBSPS
Time frame: 12 months
The study's primary endpoint will be the incidence of neuroma-related PBSPS, assessed by comparing the proportion of participants in each group who experience this condition during a follow-up period of 12 months, through review of electronic medical records.
3 secondary outcomes
Quality of Life change
Time frame: 12 months
Safety and Adverse Events
Time frame: 12 months
Pain change
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Post-mastectomy Pain Syndrome
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Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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Super-voltage PRF of Stellate Ganglion Versus Super-voltage PRF of T2 T3 Sympathetic Ganglia in Managing PMPS.
Post Mastectomy Pain Syndrome, Chronic Pain Following Surgical Procedure for Cancer
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Dex & Mastectomy Pain
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Adding Magnesium Sulphate to Combined Pectointercostal Plane and Erector Spinae Plane Blocks for Acute and Chronic Post-Mastectomy Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Kokosis, MD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Peripheral Nerve Interface in people with Post-mastectomy Pain Syndrome, run by George Kokosis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Administrator (312-942-5500, anna_t_alecci@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neuroma-related PBSPS (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.