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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The patient's highest NRS pain score within 24 hours postoperatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PNB group
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.
干预措施: Ultrasound-guided popliteal sciatic and saphenous nerve block (Procedure)
placebo group
In the control group, the procedure was identical, except that an equal volume of 0.9% saline was administered in place of ropivacaine.
干预措施: Placebo nerve block (Procedure)
结局指标
主要结局
The patient's highest NRS pain score within 24 hours postoperatively
时间窗: within 24 hours postoperatively
次要结局
- Opioid consumption within 24 hours postoperatively (OME)(within 24 hours postoperatively)
- NRS pain score at 24 hours postoperatively(at 24 hours postoperatively)
- Patient-reported ankle weakness (0-10 NRS)(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.(Within 24 hours after surgery)