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Procedure

Nerve Interface for Post-Mastectomy Pain

N/A
Waitlist Available
Led By George Kokosis, MD
Research Sponsored by George Kokosis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult female 18 to 65 years of age
Undergoing breast mastectomy with immediate reconstruction
Must not have
History of chronic pain syndrome unrelated to breast surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

"This trial will investigate whether a nerve burying procedure called RPNI, done during mastectomy with immediate breast reconstruction surgery, can help prevent long-term nerve pain after breast cancer surgery. The study will involve

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects of the RPNI procedure aren't detailed here, but it may include typical surgical risks such as infection, discomfort at the site where nerves are buried in muscle tissue, and potential neuroma formation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 65.
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I am having a breast removal with immediate reconstruction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a long-term pain condition not related to breast surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of neuroma-related PBSPS
Secondary study objectives
Pain improvement
Quality of Life improvement
Safety and Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RPNIExperimental Treatment1 Intervention
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.
Group II: No RPNI (Control)Active Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regenerative Peripheral Nerve Interface
2019
N/A
~30

Find a Location

Who is running the clinical trial?

George KokosisLead Sponsor
George Kokosis, MDPrincipal InvestigatorRush University Medical Center
~133 spots leftby Aug 2027
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