The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)
研究概览
简要总结
The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.
详细描述
Major ankle and hind foot surgery causes intense postoperative pain. Implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. According to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking.
This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis
- •American Society of Anaesthesiology Classification I-III
- •Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.
排除标准
- •Communication problems or dementia
- •Allergies to any medical product used in the study
- •Neuropathy of the sciatic or femoral nerve prior to the operation
- •Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
- •Daily use of opioids
- •Coagulation disorders
- •Infection at the site of injection or systemic infection
研究组 & 干预措施
Bupivacaine-epinephrine
10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine
干预措施: Bupivacaine-epinephrine (Drug)
Placebo
10 ml normal saline water (sodium chloride solution, 0,9%)
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)
时间窗: Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery.
Pain scores evaluated using NRS (numeric rating scale). Significant pain is defined as NRS \> 3 from the anterior and/medial side of the ankle joint. In case of significant pain, patients receive a rescue saphenous block with 10 ml bupivacaine-adrenaline.
次要结局
- Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen)(Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery))
- Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen)(At the time point when the patients report a change to significant pain during the observation period. In case of no significant pain during the observation period, sensory testing is conducted at t = 120 min.)