Pericapsular Nerve Group Block for Positional Pain and Postoperative Analgesia
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of the numerical rating scale for pain (NRS) during movement of the affected limb (extension of 20°) 30 minutes after the PENG block
研究概览
简要总结
The aims of this study are:
- Evaluate the effectiveness of the pericapsulare blockade of the femoral nerve, the accessory obturator nerve and the obturator nerve in patients with pertrochanteric fractures of the femur, during the pre-operative period for patient positioning manoeuvres (sitting position for performing spinal anaesthesia, mobilisation on the operating bed, etc.);
- Evaluate the consumption of opioids or hypnotics in the perioperative period, which are more responsible for the incidence of delirium in the elderly patient;
- Evaluate the duration and quality of postoperative analgesia and well-being.
详细描述
Pertrochanteric femoral fracture is a frequent orthopaedic emergency in the elderly and is associated with significant morbidity and mortality. Surgical reduction and subsequent fixation is the definitive therapy for most patients. Recent clinical studies show that early treatment within the first 48 hours significantly reduced mortality and major complication (pulmonary embolism, sepsis, cardiac events, renal and respiratory failure). Even though, data regarding the anaesthesiology method best suited for this intervention are somewhat controversialthe Italian Society for Anaesthesiology, Analgesia Reanimation and intensive care recommends spinal anaesthesia as the standard procedure. In addition, the Association of Anaesthetists of Great Britain and Ireland recommend this approach.
Patient mobilisation for the administration of spinal anaesthesia as well as post-operative care require effective perioperative pain management. In current practice, this is achieved by the administration of systemic analgosedative treatment. Ideally, the use of opioids or ketamine should be minimized since their side effects are major morbidity factors. Peripheral nerve blocked can be an efficient to foster pre- and postoperative analgesia and therefore minimize the need for opioids.
Currently, the psoas compartment block is considered to be the most reliable peripheral nerve block for analgesia in pertrochanteric femoral fractures, although it is technically rather difficult to perform and could be associated with serious side effects. Alternative approaches, such as the femoral nerve block, the Iata band block or the 3-in-1 block often do not possess a sufficient reliable analgesic effect in this kind of injury. Thus so far, peripheral nerve blocks are not routinely applied in clinical practice in most cases.
The anterior capsule of the hip joint is the most innervated area of the entire joint.
The nerves involved are:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a peritrocanteric femur fracture admitted to the orthopaedic ward
排除标准
- •Patient refusal
- •Lack of informed consent
- •Pathological skin alterations
- •Intertrigo at the puncture site level.
- •Allergy to any of the drugs
- •Coagulopathy
- •Use of direct oral anticoagulatns (DOACs)
研究组 & 干预措施
PENG BLOCK arm
The first arm will consist of patients that undergo PENG block administering a mixture of Ropivacaine 0.5% + Dexamethasone 4 mg in a volume of 20 ml before performing the spinal anaesthesia.
干预措施: Pericapsular nerve group blockade (Procedure)
Ketamine- Midazolam arm
The second arm consist in Patients that will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect.
干预措施: Midazolam Ketamine arm (Drug)
结局指标
主要结局
Change of the numerical rating scale for pain (NRS) during movement of the affected limb (extension of 20°) 30 minutes after the PENG block
时间窗: Change in NRS pre and 18 hours post performing the PENG block
次要结局
- Delirium(Changne in score of the 4 AT rapid clinical test pre and 18 hours post performing block)
- PONV(During the first 24 hours after discharge from the recovery room)
- Questionnaire on patient satisfaction(From the beginning of the surgical procedure until 24 hours after discharge from the recovery room)
- Rescue opiate use(During the first 24 hours after discharge from the recovery room)
研究者
Paolo Seraglio
Principal Investigator
Azienda Sanitaria dell'Alto Adige