Ankle Ligament Injury，Chronic Ankle Instability，Ankle ArthroscopyNCT07470021
Preop US-Guided Nerve Blocks for Pain & Recovery After Ankle Arthroscopy
A study testing Ultrasound-guided popliteal sciatic and saphenous nerve block in people with Ankle Ligament Injury，Chronic Ankle Instability，Ankle Arthroscopy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This randomized, double-blind controlled trial investigates the effectiveness and potential trade-offs of preoperative ultrasound-guided popliteal sciatic and saphenous nerve blocks in patients undergoing ankle arthroscopy, a procedure often performed in day-case settings but associated with significant early… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Ligament Injury，Chronic Ankle Instability，Ankle Arthroscopy
- What is being tested?
- Ultrasound-guided popliteal sciatic and saphenous nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 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
- Age between 18 and 65 years
- ASA physical status classification I-II
- Scheduled to undergo ankle arthroscopy under general anesthesia
- Expected to be available for follow-up on the day of surgery (day-case or short-stay surgery)
- Able to understand the procedures and methods of the clinical trial and voluntarily provide written informed consent
- Body mass index (BMI) between 16 and 32 kg/m²
Who cannot join
- History of severe ankle nerve injury or peripheral neuropathy
- Severe cardiac, pulmonary, hepatic, or renal dysfunction
- Chronic pain or regular use of opioid analgesics for more than 3 months
- History of extensive ankle or lower leg surgery that may affect nerve localization
- Psychiatric disorders or cognitive impairment that preclude accurate NRS pain scoring
- Pregnancy or breastfeeding
- Known allergy or contraindication to any of the study drugs
- Any other condition deemed unsuitable for inclusion by the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
zongyou pan, Doctoral degree, 0571-87783777, panzongyou@gmail.com
About this study
Official title: Effects of Preoperative Ultrasound-Guided Popliteal Sciatic and Saphenous Nerve Blocks on Early Pain and Functional Recovery After Ankle Arthroscopy: A Randomized, Double-Blind, Controlled Trial
This randomized, double-blind controlled trial investigates the effectiveness and potential trade-offs of preoperative ultrasound-guided popliteal sciatic and saphenous nerve blocks in patients undergoing ankle arthroscopy, a procedure often performed in day-case settings but associated with significant early postoperative pain and frequent opioid use. The study evaluates whether these nerve blocks can reduce early postoperative pain-measured by the highest NRS score within 24 hours-and examines their impact on functional recovery, including motor strength and ambulation. All patients receive standardized general anesthesia and multimodal analgesia, with outcomes including opioid consumption, ankle weakness, patient satisfaction, range of motion, muscle strength, hospital stay duration, and analgesia-related costs.
Read the detailed description
Background
Ankle arthroscopy is often performed in day-case or short-stay settings. Despite the minimally invasive incisions, patients frequently experience significant early postoperative ankle pain, often requiring substantial opioid analgesia, which can lead to notable opioid-related side effects. Currently, there is no standardized perioperative analgesic protocol for this procedure, and high-quality evidence is lacking on whether nerve blocks offer a meaningful net benefit in this context.
This study evaluates the net clinical benefit of preoperative popliteal sciatic and saphenous nerve blocks in ankle arthroscopy by assessing their effect on early postoperative pain control and functional mobility. Outcomes are measured through the highest pain scores within 24 hours and assessments of ambulation ability, aiming to inform clinical decision-making regarding perioperative analgesia strategies.
Hypothesis
Compared to sham blocks, preoperative popliteal sciatic and saphenous nerve blocks significantly reduce the highest postoperative pain scores (NRS 0-10) in the recovery room after ankle arthroscopy, but may also result in reduced ankle motor strength and decreased early ambulation ability.
Surgical and Anesthetic Protocol
All patients receive general anesthesia, maintained with propofol and remifentanil according to body weight. Anesthetic depth is titrated to maintain a BIS value between 40-60 while ensuring hemodynamic stability. A standardized dose of 5 mg of tropisetron is administered postoperatively to prevent PONV.
Postoperative analgesia includes celecoxib 200 mg BID and acetaminophen 500 mg every 6 hours, with oxycodone-acetaminophen (325 mg/5 mg) available as rescue analgesia if needed.
Outcome Measures
Highest NRS pain score within 24 hours postoperatively
Total opioid consumption in the first 24 hours
Average pain score at 24 hours post-op
Patient-reported ankle weakness (NRS 1-10)
Patient satisfaction with postoperative analgesia (4-point Likert scale)
Degrees of ankle plantarflexion and dorsiflexion, and MRC muscle strength grading (0-5), assessed pre-block and at discharge
Total hospital stay duration
Total costs related to anesthesia and analgesia
- Being tested
- Ultrasound-guided popliteal sciatic and saphenous nerve block, Placebo nerve block
- Keywords
- Ankle arthroscopy，Pain management，Opioid-sparing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided popliteal sciatic and saphenous nerve blockProcedure or surgery
Ultrasound-guided sciatic (20 mL) and saphenous (10 mL) nerve blocks using 0.25% ropivacaine were administered in the prone position before induction. Block success was confirmed via ultrasound (circumferential spread) and sensory loss in relevant ankle dermatomes.
Placebo nerve blockProcedure or surgery
The control group underwent the same procedure, with an equivalent volume of 0.9% normal saline injected instead of local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| PNB group | Experimental | Prior to anesthesia induction, patients received nerve blocks in the anesthesia preparation room. In the prone position, under ultrasound guidance, the anesthesiologist performed a sciatic nerve block with 20 mL and a saphenous nerve block with 10 mL of 0.25% ropivacaine, for a total volume of 30 mL. The success of the block was assessed by the anesthesiologist based on circumferential spread of the local anesthetic around the target nerves under ultrasound, along with sensory reduction over the dorsum and plantar surface of the foot, the lateral foot, and the area around the Achilles tendon. Receives: Procedure: Ultrasound-guided popliteal sciatic and saphenous nerve block |
| placebo group | Placebo comparator | In the control group, the procedure was identical, except that an equal volume of 0.9% saline was administered in place of ropivacaine. Receives: Procedure: Placebo nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's highest NRS pain score within 24 hours postoperatively
Measured: within 24 hours postoperatively
Secondary outcomes (4)
NRS pain score at 24 hours postoperatively
Measured: at 24 hours postoperatively
Opioid consumption within 24 hours postoperatively (OME)
Measured: within 24 hours postoperatively
Patient-reported ankle weakness (0-10 NRS)
Measured: Within 24 hours after surgery
Ankle plantarflexion and dorsiflexion angles, as well as manual muscle strength graded by the MRC scale (0-5), were assessed before the nerve block and at the time of discharge.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start30 Jan 2026
- Primary completion30 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 Ligament Injury，Chronic Ankle Instability，Ankle ArthroscopyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470021
- Sponsor's protocol ID
- 2026-0051
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Ultrasound-Guided Popliteal Sciatic and Saphenous Nerve Blocks on Early Pain and Functional Recovery After Ankle Arthroscopy: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07470021
- Acronym / sponsor ID
- 2026-0051
- Keywords
- Ankle arthroscopy，Pain management，Opioid-sparing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 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.
This randomized, double-blind controlled trial investigates the effectiveness and potential trade-offs of preoperative ultrasound-guided popliteal sciatic and saphenous nerve blocks in patients undergoing ankle arthroscopy, a procedure often performed in day-case settings but associated with significant early postoperative pain and frequent opioid use. The study evaluates whether these nerve blocks can reduce early postoperative pain-measured by the highest NRS score within 24 hours-and examines their impact on functional recovery, including motor strength and ambulation. All patients receive standardized general anesthesia and multimodal analgesia, with outcomes including opioid consumption, ankle weakness, patient satisfaction, range of motion, muscle strength, hospital stay duration, and analgesia-related costs.
Detailed description
Background
Ankle arthroscopy is often performed in day-case or short-stay settings. Despite the minimally invasive incisions, patients frequently experience significant early postoperative ankle pain, often requiring substantial opioid analgesia, which can lead to notable opioid-related side effects. Currently, there is no standardized perioperative analgesic protocol for this procedure, and high-quality evidence is lacking on whether nerve blocks offer a meaningful net benefit in this context.
This study evaluates the net clinical benefit of preoperative popliteal sciatic and saphenous nerve blocks in ankle arthroscopy by assessing their effect on early postoperative pain control and functional mobility. Outcomes are measured through the highest pain scores within 24 hours and assessments of ambulation ability, aiming to inform clinical decision-making regarding perioperative analgesia strategies.
Hypothesis
Compared to sham blocks, preoperative popliteal sciatic and saphenous nerve blocks significantly reduce the highest postoperative pain scores (NRS 0-10) in the recovery room after ankle arthroscopy, but may also result in reduced ankle motor strength and decreased early ambulation ability.
Surgical and Anesthetic Protocol
All patients receive general anesthesia, maintained with propofol and remifentanil according to body weight. Anesthetic depth is titrated to maintain a BIS value between 40-60 while ensuring hemodynamic stability. A standardized dose of 5 mg of tropisetron is administered postoperatively to prevent PONV.
Postoperative analgesia includes celecoxib 200 mg BID and acetaminophen 500 mg every 6 hours, with oxycodone-acetaminophen (325 mg/5 mg) available as rescue analgesia if needed.
Outcome Measures
Highest NRS pain score within 24 hours postoperatively
Total opioid consumption in the first 24 hours
Average pain score at 24 hours post-op
Patient-reported ankle weakness (NRS 1-10)
Patient satisfaction with postoperative analgesia (4-point Likert scale)
Degrees of ankle plantarflexion and dorsiflexion, and MRC muscle strength grading (0-5), assessed pre-block and at discharge
Total hospital stay duration
Total costs related to anesthesia and analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNB group | Experimental | Procedure: Ultrasound-guided popliteal sciatic and saphenous nerve blockPrior to anesthesia induction, patients received nerve blocks in the anesthesia preparation room. In the prone position, under ultrasound guidance, the anesthesiologist performed a sciatic nerve block with 20 mL and a saphenous nerve block with 10 mL of 0.25% ropivacaine, for a total volume of 30 mL. The success of the block was assessed by the anesthesiologist based on circumferential spread of the local anesthetic around the target nerves under ultrasound, along with sensory reduction over the dorsum and plantar surface of the foot, the lateral foot, and the area around the Achilles tendon. |
| placebo group | Placebo comparator | Procedure: Placebo nerve blockIn the control group, the procedure was identical, except that an equal volume of 0.9% saline was administered in place of ropivacaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- ASA physical status classification I-II
- Scheduled to undergo ankle arthroscopy under general anesthesia
- Expected to be available for follow-up on the day of surgery (day-case or short-stay surgery)
- Able to understand the procedures and methods of the clinical trial and voluntarily provide written informed consent
Key exclusion criteria (8 listed)
- History of severe ankle nerve injury or peripheral neuropathy
- Severe cardiac, pulmonary, hepatic, or renal dysfunction
- Chronic pain or regular use of opioid analgesics for more than 3 months
- History of extensive ankle or lower leg surgery that may affect nerve localization
- Psychiatric disorders or cognitive impairment that preclude accurate NRS pain scoring
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 |
|---|---|---|
| Ultrasound-guided popliteal sciatic and saphenous nerve blockUltrasound-guided sciatic (20 mL) and saphenous (10 mL) nerve blocks using 0.25% ropivacaine were administered in the prone position before induction. Block success was confirmed via ultrasound (circumferential spread) and sensory loss in relevant ankle dermatomes. | Procedure or surgery | PNB group |
| Placebo nerve blockThe control group underwent the same procedure, with an equivalent volume of 0.9% normal saline injected instead of local anesthetic. | Procedure or surgery | placebo group |
Primary outcome
The patient's highest NRS pain score within 24 hours postoperatively
Time frame: within 24 hours postoperatively
4 secondary outcomes
NRS pain score at 24 hours postoperatively
Time frame: at 24 hours postoperatively
Opioid consumption within 24 hours postoperatively (OME)
Time frame: within 24 hours postoperatively
Patient-reported ankle weakness (0-10 NRS)
Time frame: Within 24 hours after surgery
Ankle plantarflexion and dorsiflexion angles, as well as manual muscle strength graded by the MRC scale (0-5), were assessed before the nerve block and at the time of discharge.
Time frame: Within 24 hours after surgery
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 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided popliteal sciatic and saphenous nerve block in people with Ankle Ligament Injury，Chronic Ankle Instability，Ankle Arthroscopy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The patient's highest NRS pain score within 24 hours postoperatively (time frame: within 24 hours postoperatively). 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 13 Mar 2026.