Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284109
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-01-30
Brief Title:
Preoperative Pre-amputation Cryoanalgesia to Improve Post-amputation Phantom Limb Pain
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None