Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 1, 2024

Primary Completion Date

September 10, 2024

Study Completion Date

September 10, 2024

Conditions
Postoperative Pain
Interventions
DEVICE

Cryoanalgesia

Participants will receive cryoanalgesia with the The iovera° system. . The specific nerves targeted will be both the sciatic, targeted first (as distal as possible, but not more distal than the bifurcation), and femoral, targeted second (as distal as possible, but not more distal than the adductor canal). Cryoanalgesia will result from an 8-minute-long percutaneous cryoneuroablation procedure consisting of several freeze/defrost cycles. Per routine, all patients will have a nerve block with single shot ropivacaine.

DEVICE

Sham Cryoanalgesia

Participants will receive Sham cryoanalgesia with the The iovera° system. The specific nerves targeted will be both the sciatic, targeted first (as distal as possible, but not more distal than the bifurcation), and femoral, targeted second (as distal as possible, but not more distal than the adductor canal). Per routine, all patients will have a nerve block with single shot ropivacaine.

Trial Locations (1)

44195

Cleveland Clinic Foundation, Cleveland

Sponsors
All Listed Sponsors
collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

The Cleveland Clinic

OTHER

NCT06284109 - Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain | Biotech Hunter | Biotech Hunter