The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Consumption
研究概览
简要总结
Achilles tendon rupture is common, yet the value of popliteal nerve block for postoperative pain control during surgical repair remains uncertain. Despite widespread use, evidence supporting its analgesic effectiveness is limited, and both popliteal nerve block and Achilles tendon repair carry risks of nerve injury. This randomized, placebo-controlled trial will evaluate whether adding a popliteal nerve block to standard systemic analgesia improves postoperative pain and reduces opioid use in patients undergoing acute Achilles tendon rupture repair. Secondary outcomes will examine the incidence and impact of nerve complications on recovery, including return to physical activity and functional performance.
详细描述
This will be a prospective, double-blinded, randomized controlled superiority trial conducted at Women's College Hospital (WCH). The study aims to enroll 80 patients (40 per group) undergoing ambulatory surgical repair of acute Achilles tendon ruptures.
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)
盲法说明
As noted above, only the individual administering the intervention will be aware of allocation assignment. The participant and outcomes assessors will be blinded to minimize bias.
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 18 - 65
- •ASA classification: I - III
- •BMI < 35 kg/m2
- •Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure
排除标准
- •Pre-existing neurological deficits or peripheral neuropathy in the distribution of the tibial or common peroneal nerves
- •Local infection
- •Contraindication to regional anesthesia (e.g., bleeding diathesis, coagulopathy)
- •History of use of over 30 mg oxycodone or equivalent per day
- •Contraindication to any component of a standard multi-modal analgesia
- •Allergy to local anesthetics
- •History of significant psychiatric conditions that may affect patient assessment
- •Pregnancy
- •Inability to provide informed consent
- •Patient refusal of popliteal nerve blockade
- •Prior Achilles tendon surgeries on the operative leg
- •Unable to speak or read English
研究组 & 干预措施
Popliteal nerve (PN) block group
30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine
干预措施: Popliteal Nerve Block (Procedure)
Placebo Nerve Block
1 mL of saline
干预措施: Sham Block (Procedure)
结局指标
主要结局
Cumulative Opioid Consumption
时间窗: The first 24 hours after surgery
Total opioid dose administered to each patient, converted to oral morphine equivalents.
次要结局
- Adverse Events Attributable to Opioids(Evaluated at 24 and 48 hours after surgery.)
- Time to Analgesic Request(The first 24 hours after surgery)
- Adverse Events Attributable to Popliteal Block(At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery)
- Adverse Events Attributable to Opioids(Evaluated at 24 and 48 hours after surgery.)
- Pain, fatigue, and physical function(Prior to surgery and 1-year post-surgery)
- Neuropathic pain(At 1 week and 1-year post-surgery)
- Quality of Recovery(At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery)
- Postoperative Pain Score(At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.)
- Intraoperative Opioid Consumption(The first 24 hours after surgery)
- Time to Discharge(The first 24 hours after surgery)
- Area Under the Curve for Postoperative Pain(The first 24 hours after surgery)