Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome

Launched by GEORGE KOKOSIS · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical technique called the Regenerative Peripheral Nerve Interface (RPNI) to see if it can help prevent long-term nerve pain after breast surgery, specifically in women undergoing mastectomy with immediate breast reconstruction. The trial aims to find out whether this procedure, which involves protecting sensory nerves during surgery, can reduce symptoms like discomfort, numbness, and shooting pain that some women experience after surgery.

To participate in the study, women aged 18 to 65 who are scheduled for a mastectomy with reconstruction may be eligible. Those who agree to join will be randomly assigned to either receive the RPNI procedure or to follow the standard surgery without it. Participants will fill out surveys about their pain and quality of life before and at several points after the surgery, with the entire study lasting about 12 months. It’s important to know that participants will not know which group they are in during the study to ensure unbiased results.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult female 18 to 65 years of age.
• • 2. Undergoing breast mastectomy with immediate reconstruction.
• • 3. Able to provide informed consent and comply with study procedures.
• Exclusion Criteria:
• • 1. History of chronic pain syndrome unrelated to breast surgery.
• • 2. Unwillingness or inability to comply with the study's follow-up requirements.
• • 3. Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.
• • 4. Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.
• • 5. Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI.