Pain, Postoperative Clinical Trial
Official title:
Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.
NCT number | NCT06094257 |
Other study ID # | 22-09025293 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 9, 2022 |
Est. completion date | March 2033 |
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | March 2033 |
Est. primary completion date | March 2033 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age over 18 - Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction - Patient is capable and willing to provide informed consent Exclusion Criteria: - Patient has a nerve condition that does not allow for assessment of sensation - Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule - Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy - Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Breast Q scores | All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life. | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in Gender-Q scores | All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life. | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in cold detection threshold | Thermal detection measured by Medoc TSA system | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in warm detection threshold | Thermal detection measured by Medoc TSA system | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in heat pain threshold | Thermal detection measured by Medoc TSA system | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in mechanical detection threshold | Measured by MRC Opti Hair von Frey Filaments | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in two-point discrimination | Measured by MRC Opti Hair von Frey Filaments | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in mechanical pain threshold | Measured by MRC Pinprick Stimulator | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in pressure pain threshold | Measured by Medoc Pressure algometer | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in Tinel sensation | Measure on physical exam | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Primary | Change in vibration sensation | Measured by tuning fork | preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year | |
Secondary | Change in Breast Q scores long term | All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life. | Annually at 2-10 years post-operation | |
Secondary | Change in Gender Q scores long term | All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life. | Annually at 2-10 years post-operation | |
Secondary | Change in vibration sensation | Measured by tuning fork | Annually at 2-10 years post-operation | |
Secondary | Change in Tinel sensation | Measure on physical exam | Annually at 2-10 years post-operation | |
Secondary | Change in pressure pain threshold | Measured by Medoc Pressure algometer | Annually at 2-10 years post-operation | |
Secondary | Change in mechanical pain threshold | Measured by MRC Pinprick Stimulator | Annually at 2-10 years post-operation | |
Secondary | Change in two-point discrimination | Measured by MRC Opti Hair von Frey Filaments | Annually at 2-10 years post-operation | |
Secondary | Change in mechanical detection threshold | Measured by MRC Opti Hair von Frey Filaments | Annually at 2-10 years post-operation | |
Secondary | Change in heat pain threshold | Thermal detection measured by Medoc TSA system | Annually at 2-10 years post-operation | |
Secondary | Change in warm detection threshold | Thermal detection measured by Medoc TSA system | Annually at 2-10 years post-operation | |
Secondary | Change in cold detection threshold | Thermal detection measured by Medoc TSA system | Annually at 2-10 years post-operation |
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