Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA
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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% Injectable Solution, Dexamethasone 4mg, Dexmedetomidine.
- Кому может быть актуально
- Состояния в реестре: Knee Osteoarthritis. Базовые параметры: 65 лет — 100 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
- Польша
- Следующий шаг
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Официальное название
Perineural Dexamethasone Versus Perineural Dexmedetomidine as Adjuvants to Ropivacaine in iPACK and Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial
Обзор
This randomized, double-blind, controlled trial is designed to compare the analgesic efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided interspace between the popliteal artery and the capsule of the posterior knee (iPACK) and adductor canal blocks in patients undergoing primary unilateral total knee arthroplasty (TKA). Elderly participants scheduled for elective TKA will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine combined with perineural dexamethasone, or ropivacaine combined with perineural dexmedetomidine. The primary objective is to determine whether the addition of either adjuvant reduces postoperative opioid consumption compared with ropivacaine alone and to assess potential differences in analgesic efficacy between the two adjuvants. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, quality of early functional recovery, and the incidence of adverse events, including postoperative nausea and vomiting, motor impairment, and hemodynamic instability.
Подробное описание
Total knee arthroplasty (TKA) is associated with substantial postoperative pain, which may delay rehabilitation, prolong hospital stay, and increase opioid consumption. Ultrasound-guided peripheral nerve blocks are an integral component of multimodal analgesia for TKA, particularly the interspace between the popliteal artery and the capsule of the posterior knee (iPACK) block and the adductor canal block (ACB). These techniques provide effective analgesia while preserving quadriceps motor function, thereby facilitating early mobilization. Ropivacaine is the most commonly used local anesthetic for iPACK and ACB; however, its relatively limited duration often necessitates additional analgesic interventions.
Perineural adjuvants have attracted increasing interest as a means to prolong block duration and enhance the quality of peripheral nerve blockade. Dexamethasone and dexmedetomidine are among the most extensively studied adjuvants; however, their relative clinical efficacy and safety when administered perineurally in TKA remain uncertain. Dexamethasone has been shown to prolong block duration and reduce postoperative pain and opioid requirements, likely through anti-inflammatory and glucocorticoid-mediated mechanisms. Dexmedetomidine, an α2-adrenergic agonist, may further enhance analgesia and sensory block duration but has been associated with adverse effects such as sedation and bradycardia in susceptible patients. Comparative evidence between these agents in the specific context of combined iPACK and ACB is limited, and no clear consensus currently exists regarding their optimal use.
This randomized, double-blind, controlled clinical trial is designed to compare the efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided iPACK and adductor canal blocks in elderly patients undergoing primary unilateral total knee arthroplasty. Eligible participants will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine with perineural dexamethasone, or ropivacaine with perineural dexmedetomidine. All nerve blocks will be performed according to a standardized protocol by experienced anesthesiologists. Surgical, anesthetic, and postoperative analgesic management will be standardized across groups to minimize potential confounding factors. Participants, care providers, investigators, block practitioners, nursing staff, and outcome assessors will remain blinded to treatment allocation.
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, motor-sparing profile, hemodynamic effects, quality of early recovery, and the incidence of adverse events such as postoperative nausea and vomiting, hypotension, bradycardia, and neurological symptoms. Functional recovery will additionally be evaluated using standardized physiotherapy milestones.
It is hypothesized that both perineural dexamethasone and dexmedetomidine will reduce postoperative opioid consumption compared with ropivacaine alone, and that one adjuvant may demonstrate superior analgesic efficacy or a more favorable safety profile. The findings of this study may provide clinically relevant evidence to guide the selection of perineural adjuvants for iPACK and adductor canal blocks in total knee arthroplasty, with the potential to improve pain control, accelerate rehabilitation, and reduce opioid exposure in an elderly, at-risk population.
Вмешательства
- Препарат Ropivacaine 0.2% Injectable Solution
Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL for iPACK and 20 mL for ACB; adjust according to protocol). No adjuvant is added to the local anesthetic solution. - Препарат Dexamethasone 4mg
Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL + 20 mL). Preservative-free dexamethasone is added to the local anesthetic solution at a dose of (2 x 2 mg). - Препарат Dexmedetomidine
Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL + 20 mL). Dexmedetomidine is added to the local anesthetic solution at a dose of 25ug, distributed between both blocks according to the study protocol
Первичные конечные точки
- Cumulative opioid consumption in the first 24 hours after surgery [Срок оценки: 0-24 hours postoperatively]
Вторичные конечные точки (12)
- Pain intensity at rest [Срок оценки: 6 hours postoperatively]
- Pain intensity at rest [Срок оценки: 12 hours postoperatively]
- Pain intensity at rest [Срок оценки: 24 hours postoperatively]
- Pain intensity at rest [Срок оценки: 48 hours postoperatively]
- Pain intensity during mobilization [Срок оценки: 24 hours postoperatively]
- Pain intensity during mobilization [Срок оценки: 48 hours postoperatively]
- Time to first rescue analgesia [Срок оценки: 0-48 hours postoperatively]
- Incidence of postoperative nausea and vomiting (PONV) [Срок оценки: 0-48 hours postoperatively]
- Motor function of the operated limb [Срок оценки: 6 hours postoperatively]
- Motor function of the operated limb [Срок оценки: 12 hours postoperatively]
- Motor function of the operated limb [Срок оценки: 24 hours postoperatively]
- Block-related and systemic adverse events [Срок оценки: Intraoperative and up to 48 hours postoperatively]
Критерии участия
Критерии включения
- Age ≥ 65 years
- Scheduled for primary unilateral total knee arthroplasty under standardized anesthetic protocol
- ASA physical status II-III (or I-III, zależnie jak planujesz)
- Ability to understand the study procedures and provide written informed consent
Критерии исключения
- Contraindications to peripheral nerve blocks (infection at injection site, coagulopathy, patient refusal)
- Known allergy or hypersensitivity to amide local anesthetics, dexamethasone or dexmedetomidine
- Chronic opioid therapy or opioid use > 30 mg oral morphine equivalents per day in the last 3 months
- Severe hepatic or renal impairment
- Significant cognitive impairment, inability to cooperate with pain assessment
- Participation in another interventional trial affecting pain or analgesic consumption
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Польша · 1 центр
- Poznan University of Medical Sciences — Poznan
Идентификаторы
NCT: NCT07386600 · 13/2025