Cryoablation for Post Mastectomy Pain Syndrome

Emory University

Status: Completed

Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)

Treatments: Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection; Procedure: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03293940

IRB00094527

Details and patient eligibility

About

This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

Full description

This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

Participants will be randomized to receive cryoablation or a therapeutic peripheral nerve block injection (tPNB). All participants will be evaluated at baseline and after treatment at 10 days, 90 days, and 180 days via clinical visits.

The option to undergo cryoablation or tPNB will be offered to all participants at the end of the 90 day post-procedure assessment. Each subject that elects the crossover intervention will be assessed over the same time period and in an identical fashion to the initial intervention, including a final long term follow up (LTFU) assessment at 180 days post-cryoablation.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Status post breast surgical intervention, to include mastectomy, partial mastectomy, lumpectomy, or reconstruction
• Persistent pain in the distribution of the Intercostobrachial nerve: the residual breast, surgical bed, ipsilateral medial arm, and/or axilla following tissue healing (> 1 month postoperative)
• Positive response to local anesthetic nerve block, performed under imaging guidance. A positive response is defined as a ≥ 3 point change on a standard 11 point visual analog scale (VAS)
• Ability and willingness to provide informed consent

Exclusion criteria

• Active infection
• Underlying cervical segmentation or other cervical spinal anomaly that results in differential nerve root pressures
• Immunosuppression
• Uncorrectable coagulopathy
• Currently pregnant, nursing or planning to become pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Cryoablation Group

Experimental group

Description:

After an initial diagnostic visit to locate the pain causing nerve, participants randomized to this arm will receive the cryoablation procedure. Participants will have the option to crossover to tPNB 90 days post the initial intervention.

Treatment:

Procedure: Cryoablation

Control Group

Active Comparator group

Description:

After an initial diagnostic visit to locate the pain causing nerve, participants randomized to this arm will receive the nerve block procedure. Participants will have the option to crossover to cryoablation treatment 90 days post the initial intervention.

Treatment:

Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection