Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bloody Tab on the Needle:
研究概览
简要总结
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance
详细描述
Patients will be randomized into two groups:
Group A (Antithrombotic Therapy Group): 50 Patients on continuous antithrombotic therapy will receive BENG block.
Group C (Control Group): 50 Patients without antithrombotic therapy will receive BENG block.
Intervention:
PENG Block: Standardized administration of the PENG block will be performed by experienced anesthesiologists for both groups using ultrasound device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
outcomes assessor
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •diagnosis of hip fracture
- •scheduled for surgical intervention within 48 hours
- •Informed consent obtained.
排除标准
- •Allergy to local anesthetics,
- •Contraindications to the PENG block
- •inability to provide informed consent.
研究组 & 干预措施
group A: PENG block in hip fracture with antithrombotic therapy
50 patients will receive US guided PENG block and on antithrombotic therapy in hip fracture
干预措施: PENG block (Procedure)
group C: PENG block in hip fracture without antithrombotic therapy
50 patients will receive US guided PENG block without antithrombotic therapy in hip fracture
干预措施: PENG block (Procedure)
结局指标
主要结局
Bloody Tab on the Needle:
时间窗: immediately during the procedure ( first 10 minutes after PENG block)
Presence of blood on the needle during the performance of the PENG block.
Incidence of Hematoma Formation
时间窗: first 48 hours postintervention
The occurrence and severity of hematomas at the PENG block site. Measurement: Regular clinical examinations and imaging studies to assess for hematoma formation.
Rest and mobilization pain by numerical rating scale
时间窗: 1 hour and 6 hours after surgery, on the same day of surgery (D 0) and first day postoperative(D 1) at 8 a.m., 1 p.m. and 6 p.m.
post intervention to be assessed 0-10
次要结局
- Postoperative quadriceps strength(first day postoperative postoperative (12 hours after surgery))
- length of hospital stay in days(from the date of admission to the date of discharge)
- The quality of Postoperative functional recovery and the variations and differences between groups will be assessed using the validated arabic version of the quality-of-recovery 15-items score (QoR-15)(On the same day of surgery ( 12 hours after surgery) and first day postoperative)
- Incidence of Nerve Injury(after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours)
- - Perioperative opiate use(from the end of surgery to 48 hours postoperative)