Evaluation of The Effect of Ultrasound Guided Regional Blocks on Postoperative Analgesia in Hip Arthroplasty Using The Quality of Recovery-15 (QoR-15) Scale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Quality of Recovery (QoR-15 Score)
研究概览
简要总结
Hip replacement surgery (partial or total hip arthroplasty) is commonly performed in elderly patients and is associated with significant postoperative pain. Effective pain management is critical to support early mobilization, reduce complications, shorten hospital stay, and prevent postoperative delirium.This observational study evaluates the effect of two ultrasound-guided regional analgesia approaches on postoperative pain and recovery quality in patients aged 65 years and older undergoing hip arthroplasty under general anesthesia:
Group 1: Pericapsular Nerve Group (PENG) block + Lateral Femoral Cutaneous Nerve (LFCN) block Group 2: PENG block + Lumbar Erector Spinae Plane (ESP) block Both techniques are applied as part of routine clinical practice at our institution. The primary outcome is quality of recovery assessed by the QoR-15 questionnaire at 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, pain scores (NRS), incidence of postoperative delirium (NU-DESC), nausea and vomiting, and time to mobilization. Patients are also followed up by telephone at postoperative day 7 and day 30 for mortality and morbidity assessment.
详细描述
Study Design This is a prospective, observational, single-center study conducted at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey. Patients were allocated to one of two regional analgesia groups based on clinical decision-making by the anesthesia team according to surgical type, patient positioning, and clinician experience, consistent with the routine clinical practice of the institution.
Patient Population Patients aged ≥65 years, ASA physical status I-III, scheduled for elective partial or total hip arthroplasty under general anesthesia were enrolled. Patients with a Mini-Mental State Examination (MMSE) score below 24 were excluded. Written informed consent was obtained the day before surgery.
Anesthesia Protocol All patients received standardized general anesthesia: induction with propofol 2 mg/kg IV, fentanyl 2 mcg/kg IV, and rocuronium 0.6 mg/kg IV; maintenance with sevoflurane 1.5-2% and remifentanil 0.05-0.5 mcg/kg/min infusion, titrated to BIS 40-60. Standard monitoring included ECG, non-invasive blood pressure, SpO2, temperature, and BIS. Normothermia was maintained with active forced-air warming. All patients received paracetamol 1 g IV, tramadol 1 mg/kg IV, and ondansetron 4 mg IV 20 minutes before the end of surgery.
Regional Analgesia Techniques
At the end of surgery, under ultrasound guidance:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or older
- •ASA physical status I-III
- •Scheduled for elective partial or total hip arthroplasty under general anesthesia
- •Mini-Mental State Examination (MMSE) score ≥24
- •Written informed consent obtained
排除标准
- •MMSE score below 24
- •Refusal to participate
- •Known allergy to local anesthetics or study medications
- •Coagulation disorders or anticoagulant use contraindicating regional block
- •Infection at the block site
- •Pre-existing chronic pain conditions requiring opioid therapy
- •ASA physical status IV or above
研究组 & 干预措施
PENG + LFCN Block
Patients who received ultrasound-guided Pericapsular Nerve Group (PENG) block (20 ml 0.25% bupivacaine) combined with Lateral Femoral Cutaneous Nerve (LFCN) block (5 ml 0.25% bupivacaine) at the end of surgery for postoperative analgesia.
干预措施: PENG + LFCN Block (Procedure)
PENG + ESP Block
Patients who received ultrasound-guided Pericapsular Nerve Group (PENG) block (20 ml 0.25% bupivacaine) combined with Lumbar Erector Spinae Plane (ESP) block (20 ml 0.25% bupivacaine) at the end of surgery for postoperative analgesia.
干预措施: PENG + Lumbar ESP Block (Procedure)
结局指标
主要结局
Quality of Recovery (QoR-15 Score)
时间窗: 24 hours after surgery
Quality of postoperative recovery assessed using the 15-item Quality of Recovery scale (QoR-15). Scores range from 0 to 150, with higher scores indicating better recovery quality. Scores are categorized as excellent (\>135), good (122-135), moderate (90-121), or poor (\<90). Baseline (preoperative) and postoperative 24-hour scores are compared between groups.
次要结局
- Postoperative Pain Score at Rest(At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively)
- Postoperative Pain Score on Movement(At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively)
- Total Tramadol Consumption(24 hours after surgery)
- Time to First Rescue Analgesic(24 hours after surgery)
- Postoperative Nausea and Vomiting (PONV)(At 2, 4, 6, 12, 24 hours postoperatively)
- Postoperative Mortality and Morbidity(At postoperative day 7 and day 30)
- Incidence of Postoperative Delirium(At 2, 4, 6, 12, 24 hours postoperatively)