Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Mastectomy; Lymphedema

In brief

Breast cancer is the most common type of cancer in women. Removal of the breast, called "mastectomy", is performed either when there is cancer-or an increased risk of cancer-in the breast. This can result in a lot of pain during the months after surgery. Opioids-"narcotics"-are the most common pain control method provided to patients; but they frequently do not relieve enough pain, have undesirable side effects like vomiting and constipation, and are sometimes misused which can lead to addiction. Mastectomy also frequently results in long-term pain which can interfere with physical and emotional functioning; and the more pain patients have immediately after surgery, the greater the risk of developing long-term pain. Numbing the nerves with local anesthetic can decrease the amount of short- and long-term pain experienced by patients, but even the longest types of these nerve blocks last for hours or days, and not the 1-2 months of pain typically following mastectomy. So, there is reason to believe that if the nerve blocks could be extended so that they last longer than the pain from surgery, short- and long-term pain might be avoided completely without the need for opioids. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 5 minutes for each nerve, involves little discomfort, has no side effects, and cannot be misused or become addictive. After 2-3 months, the nerve returns to normal functioning. The investigators have completed a small study suggesting that a single cryoneurolysis treatment may provide potent pain relief after mastectomy. The ultimate objectives of the proposed research study are to determine if temporarily freezing the nerves that go to the breast will decrease short-term pain, opioid use, physical and emotional dysfunction, and long-term pain following mastectomy when added to current and customary postoperative analgesics. The current project is a pragmatic, multicenter, randomized, triple-masked (investigators, participants, statisticians), sham/placebo-controlled, parallel-arm, human-subjects, post-market clinical trial to determine if cryoneurolysis is an effective non-opioid treatment for pain following mastectomy.

Key facts

Study ID: NCT05444361
Run by: University of California, San Diego
People needed: 216
Starts: 2022-09-15
Expected to finish: 2028-05-14
Last updated by the study team: 2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients of at least 18 years of age
Undergoing unilateral or bilateral total or modified radical mastectomy

You may not qualify if…

Anticoagulation or bleeding disorder: introduction of the percutaneous cryoneurolysis probe has a risk of hemorrhage similar to the percutaneous insertion of a similar gauge needle; but an anticoagulated state will increase the risk of hemorrhage (aspirin in doses for cardiothoracic/stroke prophylaxis [≤ 325 mg] are acceptable).
Infection at the site of probe introduction: percutaneous insertion of the probe through a cutaneous infection would bring an unacceptable risk of introducing the infection to deeper tissues.
Pulmonary disease requiring supplemental oxygen: one theoretical risk of cryoneurolysis is a unilateral pneumothorax (not reported) which could result in a compromised pulmonary state for patients who require supplemental oxygen at baseline.
Possessing any contraindication to decreased temperature such as cryoglobulinemia, cryofibrinogenemia, cold urticaria, paroxysmal cold hemoglobinuria, or Raynaud's disease: the decreased temperature accompanying cryoneurolysis could result in local tissue/vascular compromise for patients with any of these cold-triggered syndromes/diseases.
Neurologic deficit of the 2nd-6th ipsilateral intercostal nerves: cryoneurolysis is theoretically a potent analgesic, but it does not "heal" injured nerves. Therefore, pre-existing nerve deficits will confound the analgesia-related results.
Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks, either by self-report or recorded previously in the medical record): individuals using opioids on a chronic basis will continue their baseline opioid requirements postoperatively. This will confound the analgesic results of the study.
Insulin-dependent diabetes: laboratory studies have demonstrated impaired nerve regeneration in diabetic animals, and diabetes in patients can lead to impaired regeneration of axons and recovery following investigational nerve injury65 as well as focal neuropathies such as ulnar neuropathy and carpal tunnel syndrome. Whether these findings are applicable to cryoneurolysis in patients with diabetes remains unknown, but we prefer to err on the side of caution for study participants.
Contralateral breast surgical procedure that does not include mastectomy.
Inability to remain in contact with the investigators during the study period (e.g., lack of telephone access).

Where it is running

Cedars-Sinai — Los Angeles, California, United States
University of California San Diego — San Diego, California, United States
University of Florida — Gainesville, Florida, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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