- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460310
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.
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: zongyou Pan, Doctoral degree
- Phone Number: 86+19857004757
- Email: panzongyou@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TIVA-P + PNB
The anesthesia method was intravenous anesthesia combined with peripheral nerve block.
|
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. |
|
Active Comparator: GA + PNB
The anesthesia method was general anesthesia plus peripheral nerve block.
|
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. |
|
Active Comparator: Spinal anesthesia
The method of anesthesia was 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 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of stay in Phase I PACU
Time Frame: On the day of surgery
|
On the day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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.
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
|
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)
|
On the day of surgery or postoperative day 1 (POD1)
|
|
Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention)
Time Frame: On the day of surgery or postoperative day 1 (POD1)
|
On the day of surgery or postoperative day 1 (POD1)
|
|
Patient, surgeon, and anesthesiologist self-rating of anesthesia satisfaction (Level 4 Likert scale)
Time Frame: On the day of surgery
|
On the day of surgery
|
|
The 15-item Quality of Recovery (QoR-15) score.
Time Frame: On the day of surgery or postoperative day 1 (POD1)
|
On the day of surgery or postoperative day 1 (POD1)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Wounds and Injuries
- Leg Injuries
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Ankle Injuries
- Agnosia
- Population Characteristics
- Anesthesia and Analgesia
- Demography
- Anesthesia, Conduction
- Anesthesia
- Anesthesia, Spinal
- Population Groups
Other Study ID Numbers
- 2026-0244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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