Postoperative Pain
Conditions
Keywords
Postoperative Pain, Phantom limb syndrome, Postoperative movilization, Lower limb amputation
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.
Interventions
DEVICECryoanalgesia
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.
DEVICESham 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
Pacira Pharmaceuticals, Inc
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Pre-Operative Patients will receive cryoanalgesia or sham cryoanalgesia before amputation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 3 Months | Opioid consumption measured by Morphine Equivalent Doses over 3 months after surgical leg amputation. |
| 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. |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Residual limb pain | 3 Months | Pain scores ranging from 0 - no pain to 10 - worst pain ever over 3 month after surgical leg amputation. |
Countries
United States
Outcome results
None listed