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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06964347
Status
Not Yet Recruiting

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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group Hybrid block
    Continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation.
  • Active Comparator: Group LA block
    Continuous local anesthetic infusion through the nerve block catheter.

Primary Outcome Measure

Pain scores [ Time Frame: First 24 postoperative hours ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Ban CH Tsui, MD
[email protected]
650-200-9107
Mayo ClinicJacksonvilleFlorida32224
Hari Kalagara, MD
University of IowaIowa CityIowa52242
Rakesh Sondekoppam, MD

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