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

Description

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

Study Overview

Study Details

Study overview

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.

Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain, General Physical and Emotional Disability, and Opioid Consumption: a Randomized Pilot Trial

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

Condition
Postoperative Pain
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Alparslan Turan, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-12-31