Cryoablation for Post Mastectomy Pain Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome

Conditions
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Post-Mastectomy Chronic Pain Syndrome (Disorder)

Intervention / Treatment
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* Procedure: Cryoablation
* Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation Group<br>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. | Procedure: Cryoablation<br>* The cryoablation procedure, a needle will be inserted and directed toward the target pain area. More than one needle may need to be used. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area. With the needle(s) in place, the study doctor(s) will freeze the nerve over 5 minutes. A 3 minutes thaw will follow, then a second 5 minutes freeze and a final 3minute thaw. This portion of the procedure can last from 25 to 45 minutes. Once the nerve has been properly treated, the cryoablation needle(s) will be withdrawn.<br>|
| Active Comparator: Control Group<br>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. | Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection<br>* During the nerve block procedure, a needle will be inserted and directed toward the target pain area. More than one needle may need to be used. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area and anesthetic will be injected into the targeted area. The tPNB injection consists of 4 cc of 0.25% Bupivicaine and 1 cc of 6mg/ml betamethasone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Breast Pain Intensity assessed by the Visual Analog Scale (VAS) Score | Participants' ratings of perceived pain intensity will be captured with the VAS, a 10cm horizontal line with the extremes labeled, No pain and Worst Possible Pain. Participants mark a point along the continuum and it is scored by measuring the distance, in mm, from the no pain end to the participant's mark. A greater the distance from the no pain mark to the participants mark indicates greater pain. | Baseline, Post-Intervention (24 Hours) | 
| Change in Numerical Rating Scale (NRS) of Pain Intensity Score | The NRS is an 11-point rating scale with 0 = No Pain and 10 = Pain as bad as you can imagine. Total scores range from 0-10 points, with higher scores indicating greater pain intensity. | Baseline, Post-Intervention (24 Hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change Scale (PGIC) Score | The PGIC is a comprehensive, single-item estimate of treatment-related improvement that asks participants to consider their current status compared to pre-treatment and rate it on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). Total scores range from 1 to 7; 1 representing no change and 7 representing considerable improvement. | Post-Intervention (Up to 24 Hours) | 
| Brief Pain Inventory Short Form (BPI) Score | The BPI captures two broad pain domains: 1) the sensory intensity of pain, and 2) the degree to which pain interferes with different areas of life. Scores are based on the two domains: the pain severity score is the mean of items 3-6 (pain at its worst, pain at its least). The pain interference score is the mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep,enjoyment of life). Higher pain scores indicate greater pain and greater interference with daily activities. | Post-Intervention (Up to 24 Hours) | 
| McGill Pain Questionnaire Short Form 2 (MPQ) Score | The MPQ consists of 24 assessments: 22 questions list a qualitative description of pain symptoms that patients may have felt during the past week and 1 question evaluates present pain intensity, both of which are rated on a numerical rating scale with 0= None and 10= Worst Possible; the final question evaluates the patient's overall total pain experience on a 6-item scale (no pain, mild, discomforting, distressing, horrible, excruciating). Total scores are on a continuum. The higher the total score, the pain experience for the participant increases. | Post-Intervention (Up to 24 Hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Pain, Nerve Pain, Mastectomy, Lumpectomy, Breast Reconstruction