Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy

Официальное название

Comparison of Total Intravenous, Balanced, and Spinal Anesthesia for Early Recovery Following Ankle Arthroscopy: A Multicenter, Prospective, Randomized Controlled Trial.

Обзор

Ankle arthroscopy is increasingly performed as a day-case procedure, making rapid recovery and efficient discharge critical. Anesthetic technique substantially influences postoperative recovery, yet high-quality evidence comparing anesthetic strategies in ankle arthroscopy is limited. This multicenter randomized trial compares total intravenous anesthesia with propofol plus peripheral nerve block (PNB), general anesthesia plus PNB, and spinal anesthesia, with PACU-I recovery time as the primary outcome. Secondary outcomes include postoperative pain, opioid consumption, hospital length of stay, adverse events, recovery quality, satisfaction, limb weakness, and intraoperative hemodynamics.

Подробное описание

Ankle injuries account for 15%-25% of all sports-related injuries, consistently ranking among the most common conditions encountered in sports medicine. Ankle arthroscopy, as a minimally invasive surgical technique, has become the preferred treatment modality. Today, most ankle arthroscopies are performed on a day-case or outpatient basis, where minimizing hospital length of stay is a shared goal between patients and healthcare systems.

Anesthesia, a critical component of surgical care, directly affects patient turnover and discharge efficiency. Total intravenous anesthesia with propofol (TIVA-P) has emerged as an optimized anesthetic approach, offering rapid onset and recovery, as well as reduced incidence of postoperative nausea and vomiting. While previous studies have shown that TIVA-P can significantly shorten Phase I post-anesthesia care unit (PACU-I) time, high-level clinical evidence in ankle arthroscopy is lacking. Therefore, further investigation is warranted to evaluate its potential role in improving surgical efficiency and accelerating recovery in this setting.

The aim of this study is to compare TIVA-P combined with peripheral nerve block (PNB) versus general anesthesia (GA) with PNB and spinal anesthesia in terms of PACU-I recovery time, and to determine whether clinically meaningful differences exist.

Secondary outcomes include:

Area under the curve (AUC) of the NRS pain scores within 24 hours postoperatively (at 2, 6, 12, 18, and 24 hours);

Total oxycodone/acetaminophen consumption within 24 hours postoperatively, converted to oral morphine equivalents (OME);

Total length of hospital stay, defined as time from operating room entry to discharge;

Duration of stay in PACU-II;

Incidence of postoperative adverse events (nausea, vomiting, headache, urinary retention);

QoR-15 (Quality of Recovery-15) scores;

Satisfaction ratings from patients, surgeons, and anesthesiologists (4-point Likert scale);

Patient-reported limb weakness using a 0-10 NRS scale;

Intraoperative hemodynamics, including incidence of hypotension or hypertension and the use of vasoactive medications.

Вмешательства

• Процедура Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group
  Preoperatively, all patients received ultrasound-guided peripheral nerve blocks using 0.375% ropivacaine, with a total volume of 30 mL: 20 mL was administered to the popliteal sciatic nerve, and 10 mL to the saphenous nerve. The success of the nerve block was determined by the attending anesthesiologist. Subsequently, total intravenous anesthesia (TIVA) was induced and maintained. Induction was performed with propofol 1.0-2.0 mg/kg IV bolus, and maintenance was achieved using continuous infus
• Процедура General anesthesia combined with peripheral nerve block (GA + PNB) group
  Similarly, patients received ultrasound-guided peripheral nerve blocks preoperatively, using 0.375% ropivacaine with a total volume of 30 mL: 20 mL was injected around the popliteal sciatic nerve and 10 mL around the saphenous nerve. The effectiveness of the block was assessed by the attending anesthesiologist. General anesthesia (intravenous-inhalational or balanced anesthesia) was then induced with midazolam 1-2 mg, sufentanil 20-30 µg, etomidate 12-18 mg, and rocuronium 35-40 mg. Maintena
• Процедура Spinal anesthesia
  Spinal anesthesia was performed via subarachnoid block at the L3-L4 or L4-L5 interspace, using 0.75% ropivacaine 2.5-3.5 mL (approximately 18-26 mg). If intraoperative sedation was required, propofol was continuously infused after confirmation of adequate anesthetic level, with the infusion discontinued before the end of surgery. Sedation depth was titrated by the anesthesiologist according to patient comfort and safety. If anesthesia or sedation was insufficient to ensure surgical safety or c

Первичные конечные точки

• Duration of stay in Phase I PACU [Срок оценки: On the day of surgery]

Вторичные конечные точки (6)

• Area under the curve (AUC) of NRS pain scores within 24 hours postoperatively (measured at 2, 6, 12, 18, and 24 hours) [Срок оценки: Postoperative 2, 6, 12, 18, and 24 hours]
• The oral morphine equivalent (OME) of the total additional salvage consumption of acetaminophen and oxycodone within 24 hours postoperatively. [Срок оценки: 24 hours after surgery]
• Total length of hospital stay for the patient (from admission to operating room to discharge) [Срок оценки: On the day of surgery or postoperative day 1 (POD1)]
• Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention) [Срок оценки: On the day of surgery or postoperative day 1 (POD1)]
• Patient, surgeon, and anesthesiologist self-rating of anesthesia satisfaction (Level 4 Likert scale) [Срок оценки: On the day of surgery]
• The 15-item Quality of Recovery (QoR-15) score. [Срок оценки: On the day of surgery or postoperative day 1 (POD1)]

Критерии участия

Критерии включения

• Full understanding of the study procedures and methods, with a signed written informed consent form.
• Aged 18 to 65 years, of either sex.
• Scheduled for elective unilateral minimally invasive ankle surgery.
• American Society of Anesthesiologists (ASA) physical status classification I or II.
• Body Mass Index (BMI) between 16 and 32 kg/m\^2

Критерии исключения

• Known hypersensitivity or allergy to any study medications or existing contraindications to anesthesia.
• Chronic obstructive pulmonary disease (COPD) or unstable asthma.
• History of difficult airway management, poorly controlled gastroesophageal reflux disease (GERD), or a known risk of aspiration.
• Anticipated surgical duration exceeding 3 hours.
• History of chronic preoperative opioid use or dependence.
• History of severe postoperative adverse reactions (e.g., severe postoperative nausea and vomiting).
• Pregnancy or lactation.
• History of seizure disorders or epilepsy.
• Severe peripheral neuropathy.
• Any other condition that, in the opinion of the investigator, would preclude safe participation in the study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07460310 · 2026-0244

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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