Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: TIVA-P + PNBExperimental treatment 1 intervention
Group B: GA + PNBActive comparator 1 intervention
Group C: Spinal anesthesiaActive comparator 1 intervention

Trial outcomes

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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