The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Location status: Recruiting
NCT Number: NCT07470021
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, China
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
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.
The control group underwent the same procedure, with an equivalent volume of 0.9% normal saline injected instead of local anesthetic.
Time frame: within 24 hours postoperatively
Time frame: at 24 hours postoperatively
Time frame: within 24 hours postoperatively
Time frame: Within 24 hours after surgery
Time frame: Within 24 hours after surgery
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.