Double-blinded Randomised Controlled Trial (RCT) Comparing a High Ankle Block to Placebo in Patients Treated for Ankle Pathologies
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room)
研究概览
简要总结
The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures.
Included will be all adult patients (>18a) treated surgically at our department. The standard peri-operative procedure at our clinic will no be altered but the additional high ankle block. The intraoperative opioid requirement, the Visual Analogue Scale for Pain (VAS) and the postoperative opioid requirement will be assessed and compared between the two groups
详细描述
Ankle fractures were among the most common injuries of the lower extremity. Peri-operative, multimodal pain therapy is of great importance in the surgical treatment of those injuries. Whereas simple (uni- and bimalleolar) ankle fractures are covered peri-operatively by oral pain medication and Piritramid-PCA (PCA=Patient-controlled analgesia), complex, trimalleolar fractures usually receive additional regional pain catheters (femoralis blockade and ischiadicus blockade).
Regional pain catheters have the major downside of motor paresis and are therefore critically discussed. Various studies have explored new techniques for perioperative pain therapy. An established procedure in midfoot and forefoot surgery is the foot block. It can be inserted at different heights around the ankle joint. However, the effectiveness of the high foot block has not yet been investigated for ankle fractures. The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures.
All patients who are operated on in our department due to a uni- or bimalleolar ankle fracture, who are over 18 years of age and have no serious pre-existing conditions or contraindications to local anaesthesia (LA) are eligible for inclusion.
The perioperative procedure does not change to the current treatment standard at the University Hospital Munich - Ludwig Maximilians University (LMU) except for randomization for high foot block or placebo. Both the anesthesia and the postoperative pain therapy correspond to the current treatment standard and are the same for both groups. The intraoperative opioid requirement, the VAS and the postoperative opioid requirement will be assessed.
The data is collected using the RedCap database (#19-177), which has already been reviewed by the ethics committee. The evaluation will be performed using SPSS 25.0 (IBM).
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
- Double (Participant, Care Provider)
盲法说明
Randomization will be conducted by the Principle Investigator through RedCap. The syringe is prepared under sterile setting in a separate room by a nurse not involved in any further part of the medical treatment. The syringe with unknown content will be handed to the anaesthesiologist performing the anaesthesia. Therefore the anaesthesiologist performing the block as well as the guiding the anaesthesia throughout the surgery does not know what was injected.
The total intraoperative morphine milligram equivalent dose will be automatically drawn from our anaesthesia recording program (NarcoData) and the cumulative morphine milligram equivalent dose use between skin incision and beginning Recovery Room calculated. The patient than receives the Piritramid PCA and the total morphine milligram equivalent dose use will again be drawn automatically from the machine. The VAS Score will be entered by the patient in a tablet.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >17 years and <71 years
- •Glomerular filtration rate (GFR) > 60
- •American Society of Anaesthesiologists physical status classification system (ASA) < 4
- •Independently mobile without aids before an accident
- •Informed consent
- •Uni- or bimalleolar (medial and lateral malleolus) ankle fractures requiring surgery
排除标准
- •Age <18 years; >70 years
- •GFR < 60
- •Trimalleolar fractures or fractures necessitating open reduction and internal fixation (ORIF) of the posterior malleolus
- •Not able to walk without aids (stick, rollator, etc.)
- •Allergy to local anesthetics or drugs of the postOP pain regime
- •Peripheral polyneuropathy
- •Peripheral artery disease (PAD) grade IV°
- •Depression, anxiety disorders or sleep disorders 18
- •Pregnancy
- •Denial of study participation
研究组 & 干预措施
Ropivacaine
A cumulative amount of approx. 40ml ropivacaine 0.5% (≙400mg (2x200mg) ropivacaine) is applied immediately before surgery. They are applied in a ring wall 10 cm cranially of the tip of the medial and lateral malleolus (N. peroneus superficialis (N. cutaneus dorsalis medius et intermedius, N. saphenus, N. suralis), as well as sonographically controlled (N. peroneus profundus and N. suralis)
干预措施: 40ml of Ropivacaine 0.5% Injectable Solution (Drug)
Ringer's Lactate
Analog to the Experimental Arm, but the same amount of Ringer (40ml) will be plicated instead Ropivacaine
干预措施: 40ml of Ringer's Lactate (Drug)
结局指标
主要结局
Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room)
时间窗: Begin anaesthesia to begin recovery room; the time will vary between 1 and 4 hours
The morphine equivalent doses will be calculated based on the morphines given throughout the surgery: Begin anaesthesia to begin recovery room Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room)
次要结局
- Visual Analogue pain Scale (VAS)(Will be collected at arrival at the recovery room and then 2 hours, 4 hours, 6 hours thereafter. For the further in-house duration,the VAS will be collected at 08:00 and 21:00 o'clock every day for further two days)
- Rescue medication(The Piritramid-PCA is provided as long as requested by the patient during his in-house stay. We expect the patient to request rescue medication within the first 24 hours after surgery)
- Postoperative cumulative morphine milligram equivalent dose(The Piritramid PCA will be started in the recovery room and stay with the patient until she or he does not rely on it any more. Usually, the patients keep the PCA for the first two postoperative days.)
研究者
Sebastian. F. Baumbach
Principal investigator
Ludwig-Maximilians - University of Munich