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

NANot yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Amputation
Interventions
DEVICE

Ropivacaine 0.2% + nerve stimulator set

Patients will receive a continuous local anesthetic (LA) infusion through the popliteal sciatic nerve block catheter using an infusion of ropivacaine 0.2% at a rate of 8-12 ml/h for at least 3 postoperative days. In addition, patients will receive a low-frequency peripheral nerve stimulation (PNS) via a nerve stimulator set to the pre-determined setting of adequate clinical response (determined in the preoperative area).

DRUG

Ropivacaine 0.2%

Patients will receive a continuous local anesthetic infusion through the popliteal sciatic nerve block catheter using an infusion of ropivacaine 0.2% at a rate of 8-12 ml/h for at least 3 postoperative days. In addition, patients will have an inactive PNS button for the purposes of blinding.

Trial Locations (4)

32224

Mayo Clinic, Jacksonville

52242

University of Iowa, Iowa City

94305

Stanford University, Stanford

Unknown

University of Alberta, Edmonton

All Listed Sponsors
lead

Stanford University

OTHER

NCT06964347 - Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT | Biotech Hunter | Biotech Hunter