The Early Intervention of Fascia Iliaca Compartment Block (FICB) as Pain Management for Elderly Patients With Hip Fracture to Improve Postoperative Rehabilitation: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- QoR-15 scores at 24 hours postoperatively
研究概览
简要总结
Hip fracture is a common injury in elderly patients, often requiring surgical treatment. However, these patients frequently experience severe postoperative pain, which can delay mobility and recovery, and increase the risk of complications such as delirium, pneumonia, and prolonged hospital stay.
The fascia iliaca compartment block (FICB) is a regional anesthesia technique that has been shown to provide effective pain relief for hip fracture patients. This study aims to investigate whether early administration of FICB, performed upon hospital admission before surgery, can improve postoperative rehabilitation outcomes in elderly patients with hip fracture.
This is a prospective, randomized, controlled study. A total of 144 elderly patients with hip fracture will be randomly assigned to either the FICB group or the control group. The FICB group will receive ultrasound-guided FICB after being admitted to the orthopaedic ward, while the control group will receive standard analgesic care once inside the operating room.
The primary outcome measure is Quality of Recovery-15 score (QoR-15 score) 24 hours post-surgery. Secondary outcomes include: QoR-15 score at 48 hours postoperatively, NRS scores and sleep duration and quality scores at preoperative and various postoperative time points, total perioperative consumption of opioids and other analgesic drugs, extubation time and emergence agitation during anesthesia recovery period, incidence of delirium from postoperative period to before discharge, length of hospital stay, and overall satisfaction score with pain management.
The hypothesis of this study is that early FICB intervention, compared to standard care, will lead to better pain control, earlier mobilization, shorter hospital stay, and improved overall postoperative recovery in elderly patients with hip fracture.
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
- None
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
- •Diagnosis of unilateral hip fracture (including femoral neck fracture or intertrochanteric fracture) confirmed by any imaging modality (X-ray, CT, or MRI)
- •Scheduled for hip fracture surgery under general anesthesia with endotracheal intubation (including total hip arthroplasty, hemiarthroplasty, intertrochanteric intramedullary nail fixation, closed reduction and internal fixation, etc.)
- •American Society of Anesthesiologists (ASA) physical status classification I-III
- •Able to provide written informed consent personally or via a legally authorized representative
- •Able to communicate normally in Chinese
排除标准
- •Known allergy to ropivacaine, bupivacaine, or liposomal bupivacaine
- •Presence of any contraindication to nerve block, including but not limited to: nerve injury, coagulopathy, severe infection at the injection site, exudate at the injection site, etc.
- •Pre-existing psychiatric or neurological disorders, including but not limited to: depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis
- •Pre-existing severe cardiac, pulmonary, hepatic, or renal dysfunction, including but not limited to: history of heart failure, requiring dialysis, etc.
- •Inability to communicate preoperatively (e.g., coma, dementia)
- •Preoperative pain score < 4 on Visual Analog Scale (VAS) or chronic/old hip fracture
- •Currently participating in another interventional clinical trial
- •Any other condition that, in the opinion of the investigator, would preclude evaluation of the therapeutic response or make it unlikely that the patient will complete the expected treatment course and follow-up
研究组 & 干预措施
Early Intervention Group
Patients diagnosed with hip fracture requiring surgical treatment during the study period will be screened for eligibility after providing informed consent. Eligible patients will be randomized to this group. Patients in this group will receive ultrasound-guided fascia iliaca compartment block (FICB) upon admission to the orthopedic ward, prior to surgery. On the day of surgery, general anesthesia (combined intravenous and inhalation) will be administered. Postoperatively, patient-controlled intravenous analgesia (PCIA) with sufentanil 1.5-2 μg/kg (total volume 100 mL, continuous dose 2 mL/h, bolus dose 2 mL, lockout interval 15 min) will be provided.
干预措施: Ultrasound-Guided Fascia Iliaca Compartment Block (Procedure)
Non-Early Intervention Group
Patients diagnosed with hip fracture requiring surgical treatment during the study period will be screened for eligibility after providing informed consent. Eligible patients will be randomized to this group. Patients in this group will receive ultrasound-guided fascia iliaca compartment block (FICB) in the operating room immediately before surgery (conventional timing). On the day of surgery, general anesthesia (combined intravenous and inhalation) will be administered. Postoperatively, patient-controlled intravenous analgesia (PCIA) with sufentanil 1.5-2 μg/kg (total volume 100 mL, continuous dose 2 mL/h, bolus dose 2 mL, lockout interval 15 min) will be provided.
干预措施: Ultrasound-Guided Fascia Iliaca Compartment Block (Procedure)
结局指标
主要结局
QoR-15 scores at 24 hours postoperatively
时间窗: 24 hours post-surgery
The QoR-15 score was used to evaluate the effect of early intervention with liposomal bupivacaine for fascia iliaca compartment block on improving the 24-hour postoperative quality of recovery in patients undergoing hip fracture surgery.
次要结局
- QoR-15 score at 48 hours postoperatively(48 hours post-surgery)
- NRS score from admission to 72 hours post-surgery(From admission to 72 hours post-surgery)
- Total Opioid Consumption (in Morphine Milligram Equivalents)(Daily from admission up to hospital discharge, assessed up to 30 days)
- Total Non-Opioid Analgesic Consumption(Daily from admission up to hospital discharge, assessed up to 30 days)
- Sleep Duration(Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery)
- Overall Pain Management Satisfaction Score(From admission through hospital discharge, up to an average of 30 days)
- Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)(Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery)
- Extubation Time(At the end of surgery)
- Incidence of Emergence Agitation(During PACU stay, up to 2 hours post-surgery)
- Incidence of Postoperative Delirium(Daily from the end of surgery up to hospital discharge, an average of 7 days)
- Length of Hospital Stay(From admission through hospital discharge, up to an average of 30 days)
研究者
ZhaoYanhua
Department of Anesthesiology
RenJi Hospital