WithdrawnNot Applicable

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

Stopped: Enrollment challenges

United States0Started 2024-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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. Exclusion Criteria: * 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.

What they're measuring

Phantom limb pain score

Timeframe: 3 Months

Trial details

NCT IDNCT06284109

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-10

View on ClinicalTrials.gov More Postoperative Pain trials