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

NCT06284109 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-08-11

No results posted yet for this study

Summary

Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia.

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.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Alparslan Turan, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-09-10
Completion
2024-09-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284109 on ClinicalTrials.gov