Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06964347
NA

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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

Official title: A Randomized Clinical Trial Comparing the Analgesic Efficacy of Combined Local Anesthetic Blockade and Neuromodulation (Hybrid Technique) Versus Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2025-12

Completion Date

2026-12

Last Updated

2025-05-09

Healthy Volunteers

No

Conditions

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.

Locations (4)

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