Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine 0.2% + nerve stimulator set, Ropivacaine 0.2%.
- Who it may be relevant to
- Registry conditions: Amputation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Pain scores [Time frame: First 24 postoperative hours]
Secondary outcome measures (8)
- Analgesic consumption [Time frame: At 24, 48, and 72 postoperative hours]
- Quality of recovery (QoR-15) [Time frame: At postoperative clinic visit (around 1-2 weeks)]
- Pain scores [Time frame: At 12 hour time intervals over the 72 hours]
- Brief Pain Inventory - short form [Time frame: During the preoperative assessment and at the 3 and 6 months postoperative assessments.]
- Phantom limb pain [Time frame: At 1 week, three months, 6 months and 1 year]
- Adverse events [Time frame: Duration of postoperative recovery (typically 1-2 weeks)]
- Time to ambulation [Time frame: Duration of postoperative recovery (typically 1-2 weeks)]
- Hospital length of stay [Time frame: Duration of postoperative recovery (typically 1-2 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Stanford University — Stanford
- Mayo Clinic — Jacksonville
- University of Iowa — Iowa City
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT06964347 · 73646