Cryoablation for Post Mastectomy Pain Syndrome

NACompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

January 10, 2018

Primary Completion Date

May 19, 2021

Study Completion Date

May 19, 2021

Conditions
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Interventions
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 Once the nerve has been properly treated, the cryoablation needle(s) will be withdrawn.

PROCEDURE

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."

Trial Locations (4)

30097

Emory Johns Creek Hospital, Johns Creek

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital, Atlanta

30342

Emory St. Joseph's Hospital, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT03293940 - Cryoablation for Post Mastectomy Pain Syndrome | Biotech Hunter | Biotech Hunter