Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy
Comparison of Total Intravenous, Balanced, and Spinal Anesthesia for Early Recovery Following Ankle Arthroscopy: A Multicenter, Prospective, Randomized Controlled Trial.
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
March 10, 2026
February 1, 2026
8 months
February 27, 2026
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of stay in Phase I PACU
On the day of surgery
Secondary Outcomes (6)
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
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)
Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention)
On the day of surgery or postoperative day 1 (POD1)
Patient, surgeon, and anesthesiologist self-rating of anesthesia satisfaction (Level 4 Likert scale)
On the day of surgery
- +1 more secondary outcomes
Study Arms (3)
TIVA-P + PNB
EXPERIMENTALThe anesthesia method was intravenous anesthesia combined with peripheral nerve block.
GA + PNB
ACTIVE COMPARATORThe anesthesia method was general anesthesia plus peripheral nerve block.
Spinal anesthesia
ACTIVE COMPARATORThe method of anesthesia was spinal anesthesia.
Interventions
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.
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 10, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
March 10, 2026
Record last verified: 2026-02