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

Launched by STANFORD UNIVERSITY · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to manage pain after a below-knee amputation. The study wants to find out if using a combination of a specific type of nerve stimulation along with a local anesthetic (a medication to numb the area) can provide better pain relief compared to just using the local anesthetic alone. This is important because patients who have this surgery often experience a lot of pain afterward, and the researchers aim to improve their comfort and recovery.

To participate in this trial, you need to be at least 18 years old and scheduled for a below-knee amputation. However, certain conditions may make you ineligible, such as using strong pain medications regularly before the surgery, having a history of bleeding disorders, or having certain medical devices implanted in your body. If you join the study, you can expect to receive either the combined treatment or the standard care for pain management and will be monitored for safety and effectiveness. This trial is not yet recruiting participants, so it may take some time before it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients at least 18 years of age
• • Undergoing below-knee amputation
• Exclusion Criteria:
• • 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