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NCT Number: NCT06964347

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

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.

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Key information

Conditions

Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Canada

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About this study

The primary aim of this pilot trial is to evaluate the feasibility, safety, and analgesic efficacy of the hybrid technique (combined PNS and LA-based PNB) compared to that of PNB during the hospital course in patients undergoing below-knee amputations. The secondary aims are to estimate analgesia and opioid-sparing effects at later timepoints of 3, 6, and 12 months following the surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients at least 18 years of age
  • Undergoing below-knee amputation

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Pain scores

    Time frame: First 24 postoperative hours

    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)

Secondary outcomes

  1. Analgesic consumption

    Time frame: At 24, 48, and 72 postoperative hours

    Cumulative rescue and breakthrough analgesic consumption

  2. Quality of recovery (QoR-15)

    Time frame: At postoperative clinic visit (around 1-2 weeks)

    Survey based on patient-reported outcomes. There are 15 questions based on a scale of 0-10, 0 signifying the worst outcome, 10 signifying the best, for a score range of 0-150.

  3. Pain scores

    Time frame: At 12 hour time intervals over the 72 hours

    Static and dynamic pain scores (11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain)

  4. Brief Pain Inventory - short form

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

    A self-reported scale that assesses both the severity of pain and impact of pain on daily functioning, each question assessed on an 11-point scale, where 0 represents the best outcome and 10 - the worst outcome. The score range is 0-110.

  5. Phantom limb pain

    Time frame: At 1 week, three months, 6 months and 1 year

    The incidence of phantom limb and residual limb pain in both groups

  6. Adverse events

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

    Block and opioid-related adverse events

  7. Time to ambulation

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

    Number of post-operative days until ambulation

  8. Hospital length of stay

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

    Number of post-operative days spent in hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Ban CH Tsui, MD

CONTACT

[email protected]

6502009107

Ksenia (kasimova), MD

CONTACT

[email protected]

6507889458

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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