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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

Must not have

Insulin-dependent diabetes

Contralateral breast surgical procedure that does not include mastectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected on postoperative months 3, 6, 9 and 12

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.

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.

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 below

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I am having or have had a complete or modified breast removal surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use insulin to manage my diabetes.

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I had surgery on the opposite breast that wasn't a mastectomy.

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I have nerve damage in my chest on the same side.

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I have a bleeding disorder or I am on blood thinners.

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I have an infection where a medical probe was inserted.

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I need extra oxygen to breathe properly.

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I do not have conditions that worsen with cold, like Raynaud's or cold allergies.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected on postoperative months 3, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average pain during first 2 postoperative months

Opioid consumption during first 2 postoperative months

Secondary study objectives

Additional breast surgery

Average Pain

Awakenings due to pain

+17 more

Trial 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 1 cycle of 5.5-minute \[all but 4 participants: 064-067\] or 3 minutes \[only 4 participants 064-067; change based on new laboratory data, then changed back based on inadequate freeze\] argon activation (2000 psi and 100% power) followed by a 30-second helium defrost. 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 \[all but 4 participants: 064-067\] or 3 minutes \[only 4 participants 064-067; change based on new laboratory data, then changed back based on inadequate freeze\] 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.

0 / 8Eligibility criteria met