Monocentric, Non-blinded, Prospective Randomized Parallel Group Phase IV Clinical Study to Evaluate the Efficacy of Ultrasound Guided Single Shot Block of Nervus Tibialis Posterior for Postoperative Pain Relief After Hallux Valgus Surgery.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- morphine requirement
研究概览
简要总结
Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could be superior compared to standard pain treatment. A great variability of nerve supply of the foot is well described. There are some hints that the posterior tibial nerve supplies the first metatarsal bone and the first metatarsal joint. A nerve block could reduce postoperative pain in hallux surgery. To assess the effectiveness of this investigated measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness of the tibial nerve block.
详细描述
The overall purpose is to evaluate the effectiveness of tibial nerve block for postoperative pain relief after hallux surgery. The primary objective is to assess the morphine requirement in the first 24 hours after surgery. Secondary objectives are maximum pain scores and sleeping quality in the postoperative period. Patient's satisfaction with the pain therapy and approximately nerve block duration will be asked in the final interview.
Primary study endpoint is a 50% reduction of morphine requirement with a 60% standard deviation within 24 hours after surgery. Power is 80%, the level of significance is set at 5% (p < 0,05).
Secondary endpoints are sleeping quality and maximum pain scores (maximum VAS) measured by means of postoperative questionnaire.
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
- None
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
- •Age over 18 years
- •Elective Hallux valgus surgery ("Magerl" operation technique)
排除标准
- •Patient refusal, pregnancy
- •Regular medication with opioids
- •Drug abuse
- •Contraindication for regional anesthesia
- •Known allergy against one of the study drugs
- •Polyneuropathia, or any other neurodegenerative disorders
研究组 & 干预措施
study group
single shot, posterior tibial nerve block with 5 ml of Ropivacaine 0,75% before surgery postoperative PCA pump with morphine and droperidol (DHBP®) for the next 24 hours.
干预措施: Ropivacaine 0,75% (Drug)
study group
single shot, posterior tibial nerve block with 5 ml of Ropivacaine 0,75% before surgery postoperative PCA pump with morphine and droperidol (DHBP®) for the next 24 hours.
干预措施: posterior tibial nerve block (Procedure)
study group
single shot, posterior tibial nerve block with 5 ml of Ropivacaine 0,75% before surgery postoperative PCA pump with morphine and droperidol (DHBP®) for the next 24 hours.
干预措施: morphine and droperidol (Drug)
controll Group
After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.
干预措施: morphine and droperidol (Drug)
结局指标
主要结局
morphine requirement
时间窗: 24 hours
a 50% reduction of morphine requirement with a 60% standard deviation within 24 hours after surgery. Power is 80%, the level of significance is set at 5% (p \< 0,05).
次要结局
- sleeping quality(24 hours)
研究者
Dr.med. Sabine Schoenfeld
senior consultant for anesthesia
Spitalregion Rheintal, Werdenberg, Sarganserland