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NCT Number: NCT07460310

Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group

Procedure

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 infusion of propofol at 4.8-12 mg/kg/h, with optional co-administration of dexmedetomidine for sedation.

Infusion rates were titrated by the anesthesiologist based on clinical parameters and surgical requirements.

General anesthesia combined with peripheral nerve block (GA + PNB) group

Procedure

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.

Maintenance was achieved with sevoflurane inhalation at 0.5-2.5 vol%, in combination with continuous intravenous infusions of propofol (360-600 mg/h) and remifentanil (360-900 µg/h).

Dosages were dynamically adjusted by the anesthesiologist based on hemodynamic parameters and anesthetic depth.

Spinal anesthesia

Procedure

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 completion of the procedure, rescue conversion to general anesthesia was permitted based on clinical judgment. Such events were recorded as perioperative adverse events and protocol deviations, and included in safety and protocol adherence analyses.

After surgery, all patients were transferred to the post-anesthesia care unit (PACU) for recovery. Patients were discharged to the general ward once they achieved an Aldrete score ≥9. For spinal anesthesia patients, discharge from PACU required a regr

Primary outcomes

  1. Duration of stay in Phase I PACU

    Time frame: On the day of surgery

Secondary outcomes

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

    Time frame: Postoperative 2, 6, 12, 18, and 24 hours

  2. The oral morphine equivalent (OME) of the total additional salvage consumption of acetaminophen and oxycodone within 24 hours postoperatively.

    Time frame: 24 hours after surgery

  3. Total length of hospital stay for the patient (from admission to operating room to discharge)

    Time frame: On the day of surgery or postoperative day 1 (POD1)

  4. Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention)

    Time frame: On the day of surgery or postoperative day 1 (POD1)

  5. Patient, surgeon, and anesthesiologist self-rating of anesthesia satisfaction (Level 4 Likert scale)

    Time frame: On the day of surgery

  6. The 15-item Quality of Recovery (QoR-15) score.

    Time frame: On the day of surgery or postoperative day 1 (POD1)

Study contacts

Contact information is provided by the study sponsor or research team.

zongyou Pan, Doctoral degree

CONTACT

[email protected]

86+19857004757

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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