MedTrace Logo

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

NCT06964347 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-05-09

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964347 on ClinicalTrials.gov