Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT

Starting soon · Not applicable

Conditions studied: Amputation

In brief

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 anesthetic blockade only using safe stimulation parameters in a condition associated with high postoperative pain state, i.e. a patient undergoing lower limb amputation.

Key facts

Study ID

NCT06964347

Run by

Stanford University

People needed

62

Starts

2025-12-01

Expected to finish

2026-12-01

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients at least 18 years of age
• Undergoing below-knee amputation

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Alberta — Edmonton, Canada

Full record on ClinicalTrials.gov

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