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

NCT ID: NCT06284109

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-09-10

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cryoanalgesia

Participants will receive cryoanalgesia with the The iovera° system.

Group Type: EXPERIMENTAL

Cryoanalgesia

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Sham Cryoanalgesia

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alparslan Turan, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

23-1036

Identifier Type: -

Identifier Source: org_study_id