Cryoneurolysis for Post-Mastectomy Pain
This study is testing if a procedure called cryoneurolysis can help reduce pain after a mastectomy (breast removal surgery). Mastectomy can cause significant pain, and this study aims to find a non-opioid way to manage it. Participants will receive either cryoneurolysis, where small nerves are frozen to block pain signals, or a sham (inactive) procedure. Both groups will still receive standard pain medication. Researchers will measure how much opioid pain medication you use and your average pain levels for two months after surgery to see if cryoneurolysis is effective. You may be able to join if you are at least 18 years old and are having a unilateral or bilateral mastectomy. The study is currently recruiting participants.
- Study design
- This is a randomized, triple-masked (you, your doctors, and the statisticians won't know which treatment you receive), sham-controlled study with 216 planned participants.
- What's involved
- You will have a cryoneurolysis or sham procedure. Your opioid use and pain levels will be recorded on specific days for two months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your opioid consumption and average pain will be tracked for two months after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy
At a glance
Conditions
Where it's being run
5 sites across 4 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Opioid consumption during first 2 postoperative monthsPostoperative months 1 and 2, collected on days 1, 2, 3, 4, 7, 14, 21, 30, 45 and 60; at each collection time point, opioid use for the previous 24 hours will be recorded
Cumulative opioid dose measured in oral oxycodone equivalents following recovery room discharge for 10 specific 24-hour time points over the first 2 months following surgery. With 10 time points (postoperative days 1, 2, 3, 4, 7, 14, 21, 30, 45 and 60), this will encompass 240 hours in total of the first 2 postoperative months. In order to claim that percutaneous cryoneurolysis is superior to usual and customary analgesia, at least one of Outcomes 1 and 2 must be superior while the other at least noninferior.
- Average pain during first 2 postoperative monthsPostoperative months 1 and 2, collected on days 1, 2, 3, 4, 7, 14, 21, 30, 45 and 60; at each collection time point, the "average" pain score for the previous 24 hours will be recorded
The area under the curve for the "average" daily pain scores over the first 2 postoperative months. At 10 specific time points the "average" pain score following recovery room discharge will be measured using the numeric rating scale. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10= worst imaginable pain. In order to claim that percutaneous cryoneurolysis is superior to usual and customary analgesia, at least one of Outcomes 1 and 2 must be superior while the other at least noninferior.