Eliminating Post-Mastectomy Pain and Opioids With Percutaneous Cryoneurolysis

What is the Purpose of this Study?

This study focuses on individuals who are scheduled for a mastectomy surgery that frequently results in moderate-to-severe pain. The purpose of the study is to determine whether temporarily freezing the nerves that go to the patient’s surgical site (called cryoneurolysis) will decrease postoperative pain and opioid requirements. Participants will be assigned to receive either an active cryoneurolysis treatment or a mock treatment that does not do anything. Participants will also be asked to answer questions following treatment about their pain levels, opioid use, sleep disturbances, and physical and emotional functioning.

Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

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).

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Eliminating Post-Mastectomy Pain and Opioids with Percutaneous Cryoneurolysis: A Single-Administration, Non-Opioid, Non-Addictive, Multiple-month Analgesic

Study Details

Disease Type/Condition

Other

Principal Investigator

Vijjeswarapu, Mary

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002459

ClinicalTrials.gov ID

NCT05444361

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org