Ankle SprainNCT07460310
Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy
A study testing Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group, General anesthesia combined with peripheral nerve block (GA + PNB) group and Spinal anesthesia in people with Ankle Sprain and Ankle (Ligaments); Instability (Old Injury), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Sprain, Ankle (Ligaments); Instability (Old Injury), Pain Management
- What is being tested?
- Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group, General anesthesia combined with peripheral nerve block (GA + PNB) group and Spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Sprain, Ankle (Ligaments); Instability (Old Injury), Pain Management, ERAS, Ankle Arthroscopy
- Being tested
- Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group, General anesthesia combined with peripheral nerve block (GA + PNB) group, Spinal anesthesia
- Medical subject headings
- Ankle Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) groupProcedure or 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) groupProcedure or 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 anesthesiaProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| TIVA-P + PNB | Experimental | The anesthesia method was intravenous anesthesia combined with peripheral nerve block. Receives: Procedure: Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group |
| GA + PNB | Active comparator | The anesthesia method was general anesthesia plus peripheral nerve block. Receives: Procedure: General anesthesia combined with peripheral nerve block (GA + PNB) group |
| Spinal anesthesia | Active comparator | The method of anesthesia was spinal anesthesia. Receives: Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of stay in Phase I PACU
Measured: 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)
Measured: 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.
Measured: 24 hours after surgery
Total length of hospital stay for the patient (from admission to operating room to discharge)
Measured: On the day of surgery or postoperative day 1 (POD1)
Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention)
Measured: On the day of surgery or postoperative day 1 (POD1)
Patient, surgeon, and anesthesiologist self-rating of anesthesia satisfaction (Level 4 Likert scale)
Measured: On the day of surgery
The 15-item Quality of Recovery (QoR-15) score.
Measured: On the day of surgery or postoperative day 1 (POD1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460310
- Sponsor's protocol ID
- 2026-0244
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Intravenous, Balanced, and Spinal Anesthesia for Early Recovery Following Ankle Arthroscopy: A Multicenter, Prospective, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07460310
- Acronym / sponsor ID
- 2026-0244
- Conditions
- Ankle Sprain, Ankle (Ligaments); Instability (Old Injury), Pain Management, ERAS, Ankle Arthroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIVA-P + PNB | Experimental | Procedure: Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) groupThe anesthesia method was intravenous anesthesia combined with peripheral nerve block. |
| GA + PNB | Active comparator | Procedure: General anesthesia combined with peripheral nerve block (GA + PNB) groupThe anesthesia method was general anesthesia plus peripheral nerve block. |
| Spinal anesthesia | Active comparator | Procedure: Spinal anesthesiaThe method of anesthesia was spinal anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) groupPreoperatively, 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. | Procedure or surgery | TIVA-P + PNB |
| General anesthesia combined with peripheral nerve block (GA + PNB) groupSimilarly, 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. | Procedure or surgery | GA + PNB |
| Spinal anesthesiaSpinal 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 | Procedure or surgery | Spinal anesthesia |
Primary outcome
Duration of stay in Phase I PACU
Time frame: On the day of surgery
6 secondary outcomes
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
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
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)
Incidence of postoperative adverse reactions (nausea, vomiting, headache, urinary retention)
Time frame: 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
The 15-item Quality of Recovery (QoR-15) score.
Time frame: On the day of surgery or postoperative day 1 (POD1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Total intravenous anesthesia combined with peripheral nerve block (TIVA + PNB) group, General anesthesia combined with peripheral nerve block (GA + PNB) group and Spinal anesthesia in people with Ankle Sprain and Ankle (Ligaments); Instability (Old Injury), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zongyou Pan, Doctoral degree (86+19857004757, panzongyou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of stay in Phase I PACU (time frame: On the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.