Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study

NACompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

August 25, 2018

Primary Completion Date

January 7, 2022

Study Completion Date

November 25, 2022

Conditions
MastectomyUpper Limb Amputation Below ElbowUpper Limb Amputation Above ElbowLower Limb Amputation Below KneeLower Limb Amputation Above KneeKnee ArthropathyShoulder ArthroplastyRotator Cuff RepairVideo-Assisted Thoracoscopic Surgery (VATS)Skin Grafting
Interventions
DEVICE

Cryoneurolysis (active)

Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle. Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature

DEVICE

Sham cryoneurolysis procedure

"Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.~Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature"

Trial Locations (1)

92103

UCSD Medical Center, San Diego

All Listed Sponsors
collaborator

Epimed International

INDUSTRY

collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

University of California, San Diego

OTHER