Status:
NOT_YET_RECRUITING
Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT
Lead Sponsor:
Stanford University
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This multi-site clinical trial aims to assess the efficacy and safety of combining peripheral nerve stimulation with local anesthetic nerve blockade compared to the standard of care, i.e., local anest...
Detailed Description
The primary aim of this pilot trial is to evaluate the feasibility, safety, and analgesic efficacy of the hybrid technique (combined PNS and LA-based PNB) compared to that of PNB during the hospital c...
Eligibility Criteria
Inclusion
- Patients at least 18 years of age
- Undergoing below-knee amputation
Exclusion
- Chronic opioid use (daily use within the two weeks before surgery and duration of use of more than four weeks of \> 30 mg of oxycodone per day or \> 50 of morphine milligrams per day)
- Neuromuscular deficit of the target nerve(s)
- Compromised immune system or concurrent risk of infection based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection).
- Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or another implantable neurostimulator whose stimulus current pathway may overlap
- History of bleeding disorder or chronic antiplatelet or anticoagulation therapies (other than aspirin) that require to be restarted within the first three postoperative days
- Allergy to study medications or devices (including occlusive dressings, bandages, tape, etc.)
- Incarceration
- Pregnancy
- Chronic pain for more than three months of any severity in an anatomic location other than the surgical site
- Anxiety disorder
- History of substance abuse
- Inability to consent
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06964347
Start Date
December 1 2025
End Date
December 1 2026
Last Update
May 9 2025
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University of Alberta
Edmonton, Canada