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临床试验/NCT07350044
NCT07350044已完成不适用

A Prospective Randomized Controlled Trial Comparing Femoral Nerve Block and Combined Pericapsular Nerve Group (PENG) Plus Femoral Nerve Block for Perioperative Analgesia in Geriatric Hip Fracture Surgery

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家实际入组 72 人开始时间: 2026年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Pain Score During Positioning for Spinal Anesthesia

研究概览

简要总结

Hip fracture surgery in geriatric patients is frequently associated with severe perioperative pain, which may complicate positioning for spinal anesthesia and increase perioperative opioid requirements. Regional analgesic techniques are commonly used to improve patient comfort and reduce opioid consumption in this vulnerable population. The femoral nerve block is a well-established method for analgesia in hip surgery, while the pericapsular nerve group (PENG) block has emerged as a novel technique targeting articular branches of the hip joint with potential advantages in pain control.

This prospective randomized controlled trial aims to compare the analgesic efficacy of femoral nerve block alone versus a combined pericapsular nerve group (PENG) plus femoral nerve block in geriatric patients undergoing hip fracture surgery under spinal anesthesia. The primary outcomes include perioperative pain intensity, opioid consumption within the first 24 hours postoperatively, and the need for additional analgesia during positioning for spinal anesthesia. Secondary outcomes include spinal anesthesia procedure duration, time to sensory block onset, time to first postoperative opioid requirement, and perioperative hemodynamic parameters.

The results of this study are expected to clarify whether the addition of the PENG block to femoral nerve block provides superior perioperative analgesia and improved patient comfort compared with femoral nerve block alone in geriatric hip fracture surgery.

详细描述

Hip fractures represent one of the most common orthopedic emergencies in the geriatric population and are associated with significant pain, morbidity, and mortality. Effective perioperative analgesia is essential in this fragile patient group, as inadequate pain control may contribute to delayed mobilization, increased cardiopulmonary complications, delirium, and prolonged hospital stay. Traditional opioid-based analgesic strategies are frequently associated with adverse effects such as nausea, vomiting, respiratory depression, and cognitive impairment, particularly in elderly patients. Therefore, regional anesthesia techniques have gained increasing importance in hip fracture surgery.

The hip joint has a complex sensory innervation primarily derived from the femoral, obturator, and accessory obturator nerves. The femoral nerve block is a well-established technique that provides effective analgesia for hip surgery; however, it may be associated with quadriceps muscle weakness due to motor fiber involvement, potentially delaying early mobilization. The pericapsular nerve group (PENG) block, first described in 2018, selectively targets the articular branches of the femoral, obturator, and accessory obturator nerves while largely preserving motor function. Emerging evidence suggests that the PENG block may provide effective analgesia with minimal impact on quadriceps strength.

Despite these findings, the additional analgesic benefit of combining the PENG block with the femoral nerve block remains unclear. This study is designed to evaluate whether the addition of the PENG block to a standard femoral nerve block improves perioperative analgesic outcomes in elderly patients undergoing hip surgery under spinal anesthesia.

This prospective, single-center, randomized controlled trial will be conducted at Ankara Bilkent City Hospital. A total of 68 patients aged 65 years or older, classified as American Society of Anesthesiologists (ASA) physical status I-III, and scheduled for hip surgery under spinal anesthesia will be enrolled after obtaining written informed consent. Patients will be randomly allocated into two groups: Group 1 will receive a preoperative femoral nerve block, and Group 2 will receive a combination of preoperative PENG block and femoral nerve block.

All nerve blocks will be performed approximately 30 minutes before surgery in the designated block area under standard monitoring, including electrocardiography, non-invasive blood pressure measurement, and pulse oximetry. Supplemental oxygen will be administered via nasal cannula at 2 L/min. The PENG block will be performed under ultrasound guidance using an 80-mm block needle, with 20 mL of 0.25% bupivacaine injected incrementally beneath the psoas tendon between the anterior inferior iliac spine and the iliopubic eminence. The femoral nerve block will be performed under ultrasound guidance using a 50-mm block needle, with 20 mL of 0.25% bupivacaine administered incrementally around the femoral nerve.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
治疗
盲法
开放(无盲法)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • Age 65 years and older,
  • Patients scheduled for surgery due to hip fracture,
  • American Society of Anesthesiologists (ASA) physical status I-III,
  • Body mass index between 18 and 40 kg/m²,
  • Preoperative fasting duration of approximately 8 hours,
  • Planned spinal anesthesia,
  • Ability to provide written informed consent.

排除标准

  • Age below 65 years,
  • Refusal to participate in the study,
  • Severe cognitive impairment, dementia, or Alzheimer's disease,
  • ASA physical status IV or higher,
  • Body mass index > 40 kg/m²,
  • Failed spinal anesthesia or conversion to general anesthesia,
  • Revision hip surgery,
  • Multiple trauma patients,
  • Old hip fractures (>3 weeks),
  • Active malignancy receiving chemotherapy or radiotherapy,
  • Active infection requiring antibiotic treatment (except prophylaxis),
  • Contraindications to regional anesthesia techniques,
  • Chronic steroid or immunosuppressive therapy,
  • Use of anti-inflammatory drugs,
  • Non-fasted patients,
  • Allergy or intolerance to local anesthetics, paracetamol, tramadol, or other opioids.

研究组 & 干预措施

Femoral Nerve Block

Experimental

Participants will receive a preoperative ultrasound-guided femoral nerve block performed approximately 30 minutes before surgery.

干预措施: Femoral Nerve Block (Procedure)

PENG Block + Femoral Nerve Block

Experimental

Participants will receive a combination of preoperative ultrasound-guided pericapsular nerve group (PENG) block and femoral nerve block performed approximately 30 minutes before surgery.

干预措施: Pericapsular nerve group (PENG) block plus femoral nerve block (Procedure)

结局指标

主要结局

Pain Score During Positioning for Spinal Anesthesia

时间窗: Periprocedural: from initiation of lateral decubitus positioning for spinal anesthesia to completion of the spinal anesthetic procedure (needle withdrawal following intrathecal injection).

To compare pain intensity during patient positioning for spinal anesthesia between the Femoral Nerve Block group and the combined Pericapsular Nerve Group (PENG) + Femoral Nerve Block group. Pain will be assessed using the Visual Analog Scale (VAS) at the time of lateral decubitus positioning for spinal anesthesia. The need for additional intravenous fentanyl during positioning will also be recorded.

次要结局

  • Postoperative Pain Scores Within the First 24 Hours(Within the first 24 hours postoperatively)
  • Total Opioid Consumption Within the First 24 Hours(Within the first 24 hours postoperatively.)
  • Hemodynamic Stability During Perioperative Period(From block application to 24 hours postoperatively)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

semih başkan

MD, Clinical Professor, Anesthesiology and Reanimation, Principal İnvestigator

Ankara Bilkent Sehir Hastanesi

研究点 (1)

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标识符

NCT 编号
NCT07350044
其他研究编号
TABED 1-26-2268

日期

首次提交
(8个月前)
首次发布
(8个月前)
主要完成日期
(4个月前)
研究完成日期
(4个月前)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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