A Randomized Controlled Trial Evaluating the Effect of Preoperative Pericapsular Nerve Group (PENG) Block on Positioning for Spinal Anesthesia and Postoperative Analgesia in Patients Undergoing Hip Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity during positioning for spinal anesthesia
研究概览
简要总结
Hip fractures are among the most common orthopedic traumas, particularly in elderly patients, and are usually associated with significant pain during positioning for spinal anesthesia. Adequate pain control during positioning can improve patient comfort and facilitate successful administration of anesthesia. The pericapsular nerve group (PENG) block has recently been introduced as a regional anesthesia technique that targets articular branches of the femoral, obturator, and accessory obturator nerves, and has been proposed as a method to reduce pain related to hip fracture positioning.
This study is designed to compare the efficacy of preoperative PENG block versus no block in patients undergoing proximal femoral nailing surgery under spinal anesthesia. The primary objective is to assess its effect on positioning pain using visual analog scale (VAS) scores. Secondary objectives include evaluating its impact on postoperative analgesic consumption, time to first rescue analgesic, and potential side effects.
详细描述
This is a prospective, single-center, randomized controlled trial conducted at the University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital. A total of 60 patients, aged 18-90 years, with ASA I-III status, scheduled for proximal femoral nailing (PFN) surgery due to hip fracture, were enrolled. Patients were randomized into two groups using a sealed-envelope method:
PENG Block Group: Received a preoperative ultrasound-guided pericapsular nerve group (PENG) block 30 minutes before spinal anesthesia.
Control Group: Received no block prior to spinal anesthesia.
Standard spinal anesthesia was performed in both groups. All patients received intravenous paracetamol for postoperative analgesia at regular intervals. Additional analgesia with intravenous tramadol was administered if VAS ≥ 4.
The following parameters were collected:
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
- Single (Outcomes Assessor)
盲法说明
Participants and care providers were not blinded due to the nature of the intervention. However, the outcome assessor who recorded VAS scores and postoperative analgesic consumption was blinded to group assignment to reduce potential bias.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 90 years
- •ASA (American Society of Anesthesiologists) physical status classification I-III
- •Scheduled for proximal femoral nailing due to hip fracture
- •Able to provide informed consent (or consent provided by a legal representative)
- •Willingness to comply with study procedures and follow-up assessments
排除标准
- •- ASA physical status classification IV or V
- •Refusal to provide informed consent
- •Coagulopathy or current use of anticoagulant therapy contraindicating neuraxial block
- •Local infection at the injection site
- •Known allergy or hypersensitivity to local anesthetic agents
- •Cognitive impairment or inability to cooperate with study procedures
- •Severe psychiatric illness preventing reliable pain assessment
- •Previous surgery or deformity of the hip interfering with block performance
- •Pregnancy or lactation
研究组 & 干预措施
PENG Block Group
Patients in this group received an ultrasound-guided Pericapsular Nerve Group (PENG) block prior to spinal anesthesia for hip fracture surgery. The block was performed with local anesthetic injection under ultrasound guidance, targeting the articular branches innervating the anterior hip capsule.
干预措施: Pericapsular nerve group (PENG) block (Procedure)
Control Group
Patients in this group did not receive a preoperative nerve block. They underwent spinal anesthesia directly for hip fracture surgery without prior intervention. Pain during positioning and postoperative analgesic requirements were evaluated in comparison to the PENG block group.
干预措施: Standard Spinal Anesthesia (Control) (Procedure)
结局指标
主要结局
Pain intensity during positioning for spinal anesthesia
时间窗: During spinal anesthesia positioning (within 15 minutes preoperatively)
Pain scores were recorded using the Visual Analog Scale (VAS; 0-10 cm, where 0 = no pain and 10 = worst pain imaginable) during positioning for spinal anesthesia prior to hip fracture surgery.
次要结局
- Postoperative VAS scores(0-24 hours after surgery)
- Cumulative tramadol requirement in the first 24 hours(0-24 hours after surgery)
- Time to first request for rescue analgesia(0-24 hours after surgery)
- Incidence of adverse events related to anesthesia(Intraoperative to 24 hours postoperatively)
研究者
Gülcan GÜL
Specialist in Anesthesiology and Reanimation
Dr. Lutfi Kirdar Kartal Training and Research Hospital