Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06284109
Study type	Interventional
Source	The Cleveland Clinic
Contact	Fabio Rodriguez, MD
Phone	216 444-9950
Email	rodrigf3@ccf.org
Status	Not yet recruiting
Phase	N/A
Start date	May 1, 2024
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04633850` - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting	`NCT03181620` - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation	N/A
Completed	`NCT04579354` - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia	N/A
Recruiting	`NCT06007378` - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery	N/A
Recruiting	`NCT05943015` - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks	N/A
Completed	`NCT04544228` - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy	N/A
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT03663478` - Continuous TQL Block for Elective Cesarean Section	Phase 4
Completed	`NCT04176822` - Designing Animated Movie for Preoperative Period	N/A
Completed	`NCT05170477` - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment	N/A
Not yet recruiting	`NCT04561856` - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone	Phase 4
Completed	`NCT03612947` - TAP Block in Laparoscopic Cholecystectomy.	Phase 2
Recruiting	`NCT05974501` - Pre vs Post Block in Total Knee Arthroplasty (TKA)	Phase 4
Completed	`NCT05995912` - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain	Phase 2
Completed	`NCT04571515` - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain	Phase 2
Active, not recruiting	`NCT04190355` - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain	N/A
Recruiting	`NCT05145153` - Incidence of Chronic Pain After Thoracic Surgery
Recruiting	`NCT03697278` - Monitoring Postoperative Patient-controlled Analgesia (PCA)	N/A
Completed	`NCT03650998` - Transmuscular Quadratus Lumborum Block for Total Laparoscopic Hysterectomy.	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms