Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain
- Conditions
- Postoperative Pain
- Interventions
- Device: CryoanalgesiaDevice: Sham Cryoanalgesia
- Registration Number
- NCT06284109
- Lead Sponsor
- The Cleveland Clinic
- 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.
- Detailed Description
Primary Aim: To determine preoperative cryoneurolysis improves phantom limb pain compared with no cryoneurolysis. Estimate the standard deviation of phantom limb pain score at baseline and post-treatment (Day 0), Days 1 and 2; Weeks 1, 2, 3, and Months 1, 2 and 3. The investigators will consider using the upper limit of the 75% confidence interval to plan the sample size of future larger trial.
Hypothesis 1: Preoperative cryoneurolysis reduces phantom limb pain over 3 month after surgical leg amputation compared with no cryoneurolysis.
Secondary Aim 1: To determine if preoperative cryoneurolysis improves mobility after lower limb amputation compared with no cryoneurolysis.
Hypothesis 1: Preoperative cryoneurolysis improves mobilization (as measured with accelerometer) over 3 the month after surgical leg amputation compared with no cryoneurolysis.
Secondary Aim 2: To determine if preoperative cryoneurolysis improves general physical and emotional disability after lower limb amputation compared with no cryoneurolysis.
Hypothesis 2: Preoperative cryoneurolysis reduces general physical and emotional disability (as measured with the World Health Organization Disability Assessment) over the 3 month after surgical leg amputation compared with no cryoneurolysis.
Secondary Aim 3: To determine if preoperative cryoneurolysis decreases opioid use after lower limb amputation compared with no cryoneurolysis.
Hypothesis 3: Preoperative cryoneurolysis reduces opioid consumption over the 3 month after surgical leg amputation compared with no cryoneurolysis.
Exploratory Aims:
Hypothesis 1: Preoperative cryoneurolysis reduces residual limb pain over the 3 months after surgical leg amputation compared with no cryoneurolysis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryoanalgesia Cryoanalgesia Participants will receive cryoanalgesia with the The iovera° system. Sham Cryoanalgesia Sham Cryoanalgesia Participants will receive Sham cryoanalgesia with the The iovera° system.
- Primary Outcome Measures
Name Time Method Phantom limb pain score 3 Months Pain scores ranging from 0 - "no pain" to 10 - "worst pain ever" over 3 month after surgical leg amputation.
- Secondary Outcome Measures
Name Time Method General physical and emotional disability 3 Months General physical and emotional disability measured with the World Health Organization Disability Assessment. Level of disability is described as none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4).
Mobility 3 Months Number of steps measured with accelerometer integrated into the Fitbit Inspire 3 Health \&-Fitness-Tracker) over 3 the month after surgical leg amputation compared with no cryoneurolysis.
Opioid consumption 3 Months Opioid consumption measured by Morphine Equivalent Doses over 3 months after surgical leg amputation.
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States