Comparison of Total Intravenous, Balanced, and Spinal Anesthesia for Early Recovery Following Ankle Arthroscopy: A Multicenter, Prospective, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Duration of stay in Phase I PACU
研究概览
简要总结
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.
详细描述
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);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Owing to the nature of the anesthetic interventions, anesthesiologists were not blinded to group allocation. However, all postoperative outcome assessors, PACU personnel responsible for recovery assessment, follow-up investigators, and data analysts were blinded to treatment assignment.
Randomization was performed by an independent investigator, and group allocation was concealed from investigators involved in postoperative care and outcome assessment throughout the study period.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
TIVA-P + PNB
The anesthesia method was intravenous anesthesia combined with peripheral nerve block.
干预措施: Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group (Procedure)
GA + PNB
The anesthesia method was general anesthesia plus peripheral nerve block.
干预措施: General anesthesia combined with peripheral nerve block (GA + PNB) group (Procedure)
Spinal anesthesia
The method of anesthesia was spinal anesthesia.
干预措施: Spinal anesthesia (Procedure)
结局指标
主要结局
Duration of stay in Phase I PACU
时间窗: On the day of surgery
次要结局
- The 15-item Quality of Recovery (QoR-15) score.(On the day of surgery or postoperative day 1 (POD1))
- The oral morphine equivalent (OME) of the total additional salvage consumption of acetaminophen and oxycodone within 24 hours postoperatively.(24 hours after surgery)
- Total length of hospital stay for the patient (from admission to operating room to discharge)(On the day of surgery or postoperative day 1 (POD1))
- Area under the curve (AUC) of NRS pain scores within 24 hours postoperatively (measured at 2, 6, 12, 18, and 24 hours)(Postoperative 2, 6, 12, 18, and 24 hours)
- Patient, surgeon, and anesthesiologist self-rating of anesthesia satisfaction (Level 4 Likert scale)(On the day of surgery)
- Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention)(On the day of surgery or postoperative day 1 (POD1))