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

NCT06964347 | Not Yet Recruiting FDA Device

• 1 other identifier: 73646
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

peripheral nerve stimulation; neuromodulation; peripheral nerve block; post-amputation pain; below-knee amputation

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Decrease in the proportional incidence of severe or intolerable pain scores (11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain)

  First 24 postoperative hours

Secondary Outcomes (8)

• Analgesic consumption

  At 24, 48, and 72 postoperative hours

• Quality of recovery (QoR-15)

  At postoperative clinic visit (around 1-2 weeks)

• Pain scores

  At 12 hour time intervals over the 72 hours

• Brief Pain Inventory - short form

  During the preoperative assessment and at the 3 and 6 months postoperative assessments.

• Phantom limb pain

  At 1 week, three months, 6 months and 1 year

Study Arms (2)

Group Hybrid block

EXPERIMENTAL

Continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation.

Device: Ropivacaine 0.2% + nerve stimulator set

Group LA block

ACTIVE COMPARATOR

Continuous local anesthetic infusion through the nerve block catheter.

Drug: Ropivacaine 0.2%

Interventions

Ropivacaine 0.2% + nerve stimulator set DEVICE

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).

Group Hybrid block

Ropivacaine 0.2% DRUG

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.

Group LA block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Alberta

Edmonton, Canada

Location

Central Study Contacts

Ban CH Tsui, MD

CONTACT

6502009107; bantsui@stanford.edu

Ksenia (kasimova), MD

CONTACT

6507889458; kasimova@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study team members collecting the data and participating subjects will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Med Ctr Line

Model Details: Comparison of two groups: 1) Group Hybrid block 2) Group LA block

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: May 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)