Cryoablation for Post Mastectomy Pain Syndrome

Post-Mastectomy Chronic Pain Syndrome (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293940
• Other study ID #: IRB00094527
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: May 19, 2021

Study information

• Verified date: October 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Post-Mastectomy Chronic Pain Syndrome (Disorder)
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Cryoablation
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.
• Therapeutic Peripheral Nerve Block (tPNB) Injection
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.

Locations

Country	Name	City	State
United States	Emory St. Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory Johns Creek Hospital	Johns Creek	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lost to Follow Up Rate	The number of participants who cannot be contacted prior to completing all study visits.	Duration of Study (Up to 180 Days)
Other	Death Rate	The number of deaths that occur throughout the duration of the study.	Duration of Study (Up to 180 Days)
Other	Participant Withdrawal Rate	The number of participants who withdraw from the study prior to completing all visits and after providing consent for participation.	Duration of Study (Up to 180 Days)
Other	Declination Rate	The number of eligible participants who decline study participation after being approached to participate.	Duration of Study (Up to 180 Days)
Other	Screen Failure Rate	The number of participants who are not eligible for study participation after conducting screening procedures.	Duration of Study (Up to 180 Days)
Other	Percent Post Mastectomy Participants Enrolled	Of the total number of post mastectomy patients at all sites, the percentage of patients who have consented to study participation.	Post Study Completion (Up to 2 Years)
Other	Participant Retention Rate	The number of participants who sign consent and complete all study visits.	Duration of Study (Up to 180 Days)
Other	Total Recruitment Number	The total number of participants recruited to the study.	Duration of Study (Up to 180 Days)
Other	Frequency of Breakthrough Pain Events	The frequency of breakthrough pain events that require emergency or rescue analgesic use measured in hours.	Duration of Study (Up to 180 Days)
Other	Number of Breakthrough Pain Events	The number of breakthrough pain events that require emergency or rescue analgesic use reported during study visits.	Duration of Study (Up to 180 Days)
Other	Proportion of Participants that Experience Adverse Events	The number of participants who experience adverse events divided by the total number of participants.	Duration of Study (Up to 180 Days)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)