A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Accumulated opioid consumption
研究概览
简要总结
The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
详细描述
Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective major ankle surgery
- •total ankle arthroplasty
- •subtalar fusion
- •ankle fusion (non arthroscopic)
排除标准
- •coagulation abnormalities
- •infection in the region of needle insertion
- •systemic infection
- •preoperative consumption of high dose opioid
- •preoperative sciatic or femoral nerve neuropathy
- •preoperative sensory deficit in either of the lower extremities
- •Charcot-Marie-Tooth disorder
- •diabetic neuropathy
- •severe peripheral vascular disease
- •allergy to local anesthetics
- •lack of understanding of Numeric Rank Scale (NRS)
- •communication problems
- •body mass index above 35
- •bilateral continuous sciatic nerve block
- •lack of consent
结局指标
主要结局
Accumulated opioid consumption
时间窗: First 48 hours postoperative
次要结局
- Success rate for saphenous nerve analgesia(Postoperative, first 48 hours)
- Success rate for clinical analgesia of foot and ankle(Postoperative, first 48 hours)
- Success rate for tibial and peroneal nerve block(Postoperative, first 48 hours)
- Localisation of worst pain(Postoperative, first 48 hours)
- Cost-effectiveness(2 first postoperative days)