Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 35
- Locations
- 8
- Primary Endpoint
- Change in Numerical Rating Scale (NRS) of Pain Intensity Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Numerical Rating Scale (NRS) of Pain Intensity Score
Time Frame: Baseline, Post-Intervention (24 Hours)
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.
Change in Breast Pain Intensity assessed by the Visual Analog Scale (VAS) Score
Time Frame: Baseline, Post-Intervention (24 Hours)
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.
Secondary Outcomes
- Brief Pain Inventory Short Form (BPI) Score(Post-Intervention (Up to 24 Hours))
- Patient Global Impression of Change Scale (PGIC) Score(Post-Intervention (Up to 24 Hours))
- McGill Pain Questionnaire Short Form 2 (MPQ) Score(Post-Intervention (Up to 24 Hours))
Investigators
John Prologo
Assistant Professor
Emory University