Comparison of Postoperative Analgesic Efficacy of Quadroiliac Plane Block and Pericapsular Nerve Group (PENG) Block in Femoral Fractures: A Multicenter Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
This prospective, multicenter study will compare the postoperative analgesic efficacy of the Quadroiliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) block in patients undergoing femoral neck fracture surgery. Eligible patients will be randomly assigned to receive one of the blocks postoperatively under spinal anesthesia. The blocks will be administered by experienced anesthesiologists, and informed consent will be obtained from all participants.
Pain levels will be assessed using the visual analog scale (VAS) at rest and during movement at 0, 6, 12, and 24 hours post-surgery. Opioid consumption will be recorded through patient-controlled analgesia (PCA), and any need for rescue analgesia will be evaluated. Routine postoperative pain management will also include intravenous paracetamol.
详细描述
This prospective, multicenter, observational study will be conducted at Başakşehir Çam and Sakura City Hospital and Kanuni Sultan Süleyman Training and Research Hospital. The study will include patients aged 18 and older, with an ASA score of I-II-III, undergoing femoral neck fracture surgery under spinal anesthesia. Patients with no history of bleeding diathesis, anticoagulant use, or allergies to the drugs used in the study, and without neuropathic diseases such as diabetes mellitus, will be randomly assigned to receive either the Pericapsular Nerve Group (PENG) block or the Quadroiliac Plane Block (QIPB) postoperatively.
Informed consent will be obtained from all patients, and detailed explanations of both blocks will be provided. Randomization will be performed using a computer program, assigning patients to either block method. Sealed envelopes will be provided to the anesthesiologists, who will apply the block indicated in the envelope at the end of surgery. Both blocks will be performed by experienced anesthesiologists, and only patients operated on under spinal anesthesia will be included in the study.
PENG Block Procedure:
With the patient in the supine position, the ultrasound probe is placed transversely over the anterior superior iliac spine (ASIS). After identifying the ASIS, the transducer is aligned with the pubic ramus and rotated approximately 45 degrees to become parallel to the inguinal crease. The transducer is moved medially until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and psoas tendon are clearly visualized as anatomical landmarks. After confirming the correct location with saline injection, 50 mg of 0.25% bupivacaine will be administered.
QIP Block Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Patients and their relatives have provided informed consent,
- •Patients aged 18 years or older undergoing femoral fracture surgery,
- •ASA score of I-III,
- •No history of bleeding diathesis,
- •No history of anticoagulant use that contraindicates block application according to guidelines,
- •No history of neuropathic diseases such as Diabetes Mellitus,
- •No known allergy to local anesthetics.
排除标准
- •Lack of informed consent from the patient or their relatives,
- •Development of complications during the surgical procedure,
- •Need for revision surgery,
- •Patient's desire to withdraw from the study,
- •Patients under the age of 18,
- •ASA score of IV or higher,
- •Patients with a history of bleeding diathesis,
- •History of anticoagulant use that contraindicates block application according to guidelines,
- •Emergency surgeries,
- •History of allergy to local anesthetics,
- •History of neuropathic diseases,
- •Inability to comply with patient-controlled analgesia (PCA) systems.
结局指标
主要结局
opioid consumption
时间窗: 1 day
Opioid consumption in 24 hours will compared between these two block
次要结局
- Visual Analogue Scale(1 day)
研究者
Engin Ihsan Turan
M.D.
Kanuni Sultan Suleyman Training and Research Hospital