Clinical trial NCT03293940: Cryoablation for Post Mastectomy Pain Syndrome
Official title: Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)
Keywords: Breast Pain
Nerve Pain
Mastectomy
Lumpectomy
Breast Reconstruction
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Breast Pain Intensity assessed by the Visual Analog Scale (VAS) Score
timeFrame: Baseline, Post-Intervention (24 Hours)
measure: Change in Numerical Rating Scale (NRS) of Pain Intensity Score
timeFrame: Baseline, Post-Intervention (24 Hours)
Secondary outcomes:
measure: Patient Global Impression of Change Scale (PGIC) Score
timeFrame: Post-Intervention (Up to 24 Hours)
measure: Brief Pain Inventory Short Form (BPI) Score
timeFrame: Post-Intervention (Up to 24 Hours)
measure: McGill Pain Questionnaire Short Form 2 (MPQ) Score
timeFrame: Post-Intervention (Up to 24 Hours)
Other outcomes:
measure: Lost to Follow Up Rate
timeFrame: Duration of Study (Up to 180 Days)
measure: Death Rate
timeFrame: Duration of Study (Up to 180 Days)
measure: Participant Withdrawal Rate
timeFrame: Duration of Study (Up to 180 Days)
measure: Declination Rate
timeFrame: Duration of Study (Up to 180 Days)
measure: Screen Failure Rate
timeFrame: Duration of Study (Up to 180 Days)
measure: Percent Post Mastectomy Participants Enrolled
timeFrame: Post Study Completion (Up to 2 Years)
measure: Participant Retention Rate
timeFrame: Duration of Study (Up to 180 Days)
measure: Total Recruitment Number
timeFrame: Duration of Study (Up to 180 Days)
measure: Frequency of Breakthrough Pain Events
timeFrame: Duration of Study (Up to 180 Days)
measure: Number of Breakthrough Pain Events
timeFrame: Duration of Study (Up to 180 Days)
measure: Proportion of Participants that Experience Adverse Events
timeFrame: Duration of Study (Up to 180 Days)
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: John Prologo, MD
role: PRINCIPAL_INVESTIGATOR
References: