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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284109
• Other study ID #: 23-1036
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: Fabio Rodriguez, MD
• Phone: 216 444-9950
• Email: rodrigf3[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Phantom Limb
• Postoperative Pain

Intervention

Device:
• Cryoanalgesia
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.
• Sham 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual limb pain	Pain scores ranging from 0 - "no pain" to 10 - "worst pain ever" over 3 month after surgical leg amputation.	3 Months
Primary	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	Mobility	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.	3 Months
Secondary	General physical and emotional disability	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).	3 Months
Secondary	Opioid consumption	Opioid consumption measured by Morphine Equivalent Doses over 3 months after surgical leg amputation.	3 Months