Набор скоро начнётся NCT06964347

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

Без фазы С лечением Amputation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ropivacaine 0.2% + nerve stimulator set, Ropivacaine 0.2%.
Кому может быть актуально: Состояния в реестре: Amputation. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство 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).
Препарат 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.

Первичные конечные точки

Pain scores [Срок оценки: First 24 postoperative hours]

Вторичные конечные точки (8)

Analgesic consumption [Срок оценки: At 24, 48, and 72 postoperative hours]
Quality of recovery (QoR-15) [Срок оценки: At postoperative clinic visit (around 1-2 weeks)]
Pain scores [Срок оценки: At 12 hour time intervals over the 72 hours]
Brief Pain Inventory - short form [Срок оценки: During the preoperative assessment and at the 3 and 6 months postoperative assessments.]
Phantom limb pain [Срок оценки: At 1 week, three months, 6 months and 1 year]
Adverse events [Срок оценки: Duration of postoperative recovery (typically 1-2 weeks)]
Time to ambulation [Срок оценки: Duration of postoperative recovery (typically 1-2 weeks)]
Hospital length of stay [Срок оценки: Duration of postoperative recovery (typically 1-2 weeks)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет