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

NCT06284109 | Withdrawn DMC FDA Device

• 1 other identifier: 23-1036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postoperative Pain; Phantom limb syndrome; Postoperative movilization; Lower limb amputation

Outcome Measures

Primary Outcomes (1)

• Phantom limb pain score

  Pain scores ranging from 0 - "no pain" to 10 - "worst pain ever" over 3 month after surgical leg amputation.

  3 Months

Secondary Outcomes (3)

• Mobility

  3 Months

• General physical and emotional disability

  3 Months

• Opioid consumption

  3 Months

Other Outcomes (1)

• Residual limb pain

  3 Months

Study Arms (2)

Cryoanalgesia

EXPERIMENTAL

Participants will receive cryoanalgesia with the The iovera° system.

Device: Cryoanalgesia

Sham Cryoanalgesia

SHAM COMPARATOR

Participants will receive Sham cryoanalgesia with the The iovera° system.

Device: Sham Cryoanalgesia

Interventions

Cryoanalgesia DEVICE

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.

Cryoanalgesia

Sham Cryoanalgesia DEVICE

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.

Sham Cryoanalgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years of age.
• Scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone.

You may not qualify if:

• Pregnancy
• Incarceration
• Morbid obesity (body mass index greater than 40 kg/m2
• Contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria, or Reynaud's syndrome.
• Investigator opinion that the potential subject is a poor candidate for this trial.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Phantom Limb

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Alparslan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will receive nerve blocks with Local anesthetic. Participants will be Randomized on a 1:1 fashion to cryoanalgesia or sham cryoanalgesia, based on computer-generated codes and use random-sized blocks. Patients will not be told which group they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-Operative Patients will receive cryoanalgesia or sham cryoanalgesia before amputation.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 28, 2024
• Study Start: June 1, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

US (1)