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Procedure
Cryoneurolysis for Post-Mastectomy Pain
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing unilateral or bilateral total or modified radical mastectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected on postoperative months 3, 6, 9 and 12
Awards & highlights
Study Summary
This trial will test whether freezing the nerves that go to the breast can decrease short-term pain, opioid use, physical and emotional dysfunction, and long-term pain following mastectomy when added to current and customary postoperative analgesics.
Who is the study for?
This trial is for adults over 18 years old who are undergoing a mastectomy. It's not suitable for those with infections at the surgery site, chronic opioid users, patients having certain other breast procedures, or individuals unable to stay in contact with researchers. People on blood thinners, needing supplemental oxygen, with cold-triggered diseases or nerve damage in the chest area, and insulin-dependent diabetics can't participate.Check my eligibility
What is being tested?
The study tests if cryoneurolysis—a technique that temporarily freezes nerves—can reduce pain after mastectomy without opioids. Participants will be randomly assigned to receive either cryoneurolysis or a sham procedure (placebo), and neither they nor the investigators know which one they're getting.See study design
What are the potential side effects?
Cryoneurolysis has minimal discomfort and no side effects reported; it's non-addictive and reversible within months as nerves return to normal function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having or have had a complete or modified breast removal surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected on postoperative months 3, 6, 9 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected on postoperative months 3, 6, 9 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average pain during first 2 postoperative months
Opioid consumption during first 2 postoperative months
Secondary outcome measures
Additional breast surgery
Average Pain
Awakenings due to pain
+17 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: CryoneurolysisActive Control1 Intervention
Cryoneurolysis of the 2nd-6th thoracic intercostal nerves will be treated on the ipsilateral surgical side (bilaterally for bilateral surgical procedures): for each nerve the cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods (Epimed) or 1 cycle of 5.5 minutes of argon and 30 seconds of helium (Varian). For active probes, the gas will be deployed to the tip where a drop in temperature to approximately -70°C will result in cryoneurolysis.
Group II: Sham ProcedurePlacebo Group1 Intervention
Sham cryoneurolysis of the 2nd-6th thoracic intercostal nerves will be applied on the ipsilateral surgical side (bilaterally for bilateral surgical procedures): for each nerve the cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods (Epimed) or 1 cycle of 5.5 minutes of argon and 30 seconds of helium (Varian). However, for sham probes, the gas is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,419 Total Patients Enrolled
2 Trials studying Mastectomy
159 Patients Enrolled for Mastectomy
Department of Defense Congressionally Directed Medical Research ProgramUNKNOWN
1 Previous Clinical Trials
360 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I use insulin to manage my diabetes.I had surgery on the opposite breast that wasn't a mastectomy.I have nerve damage in my chest on the same side.I have a bleeding disorder or I am on blood thinners.I have an infection where a medical probe was inserted.I need extra oxygen to breathe properly.I do not have conditions that worsen with cold, like Raynaud's or cold allergies.I am 18 years old or older.I am having or have had a complete or modified breast removal surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Procedure
- Group 2: Cryoneurolysis
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being taken in for this investigation?
"Per the clinicaltrials.gov listing, this medical trial is not currently recruiting any new participants. The data was first posted on September 15th 2022 and most recently updated October 15th of the same year. Nevertheless, 76 other trials are open for patient enrollment at present."
Answered by AI
How many physical sites are involved in the application of this trial?
"Walter Reed National Military Medical Center in Bethesda, Maryland; University of California San Diego in San Diego, Ohio; Cleveland Clinic in Cleveland, Florida plus 6 more sites are all operating this clinical trial."
Answered by AI
What is the intended outcome of this medical investigation?
"This medical trial's primary outcome seeks to quantify opioid intake during the first two postoperative months. Pain scores will be recorded on days 1, 2, 3, 4, 7, 14 21 30 45 and 60 in order to measure this metric. Secondary objectives include depression screening with PHQ-2 (Patient Health Questionnaire), masking assessment and count of awakenings due to pain each night."
Answered by AI
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