Effect of Pericapsular Nerve Group (PENG) Block Added to Spinal Anesthesia on Postoperative Delirium in Older Adults Undergoing Primary Total Hip Arthroplasty: A Prospective, Randomized, Assessor-Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium is a common and serious complication in older adults undergoing total hip arthroplasty, associated with prolonged hospitalization, increased morbidity, delayed rehabilitation, and long-term cognitive decline. Modifiable perioperative risk factors include uncontrolled postoperative pain, opioid consumption, impaired early mobilization, and systemic inflammatory response.
The Pericapsular Nerve Group (PENG) block is a regional anesthesia technique targeting the sensory innervation of the anterior hip capsule and may provide effective analgesia while preserving motor function. Improved pain control and opioid reduction may decrease the incidence of postoperative delirium.
This prospective, randomized, parallel-group controlled trial aims to evaluate whether the addition of ultrasound-guided PENG block to spinal anesthesia reduces the incidence of postoperative delirium within 72 hours after primary total hip arthroplasty in patients aged 65 years or older. Delirium will be assessed using the Confusion Assessment Method (CAM) by blinded outcome assessors.
Secondary outcomes include postoperative opioid consumption, pain intensity (NRS), time to first rescue opioid, postoperative nausea and vomiting, time to mobilization, block-related adverse events, and perioperative inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and monocyte-to-lymphocyte ratio).
The study will enroll 144 patients randomized 1:1 to spinal anesthesia alone or spinal anesthesia plus PENG block.
详细描述
Postoperative delirium is a frequent and serious complication in older adults undergoing major orthopedic surgery, including total hip arthroplasty. Its incidence in this population ranges from 10% to 30% and is associated with prolonged hospital stay, increased healthcare costs, delayed functional recovery, long-term cognitive impairment, and increased mortality. Among modifiable perioperative risk factors, inadequate pain control, higher opioid consumption, postoperative nausea and vomiting, sleep disturbances, delayed mobilization, and systemic inflammatory response play an important role.
Regional anesthesia techniques may reduce delirium risk by improving analgesia, decreasing opioid requirements, and attenuating surgical stress and inflammatory response. The Pericapsular Nerve Group (PENG) block is an ultrasound-guided regional anesthesia technique targeting the articular branches supplying the anterior hip capsule. It has been shown to provide effective analgesia after hip surgery while largely preserving quadriceps motor function, potentially facilitating early mobilization.
This study is a prospective, randomized, parallel-group controlled trial designed to evaluate whether the addition of ultrasound-guided PENG block to spinal anesthesia reduces the incidence of postoperative delirium in patients aged 65 years or older undergoing primary elective total hip arthroplasty.
Eligible patients (ASA II-III) will be randomized in a 1:1 ratio to receive:
spinal anesthesia with standard multimodal postoperative analgesia (control group), or spinal anesthesia combined with ultrasound-guided PENG block plus standard multimodal postoperative analgesia (intervention group).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years
- •Scheduled for elective primary total hip arthroplasty
- •Planned spinal anesthesia
- •ASA physical status II-III
- •Ability to provide written informed consent
- •Ability to communicate and reliably assess pain using the Numeric Rating Scale (NRS)
- •Expected postoperative hospitalization ≥ 72 hours
排除标准
- •Pre-existing delirium, acute psychosis, or active major psychiatric disorder
- •Documented severe dementia or inability to provide informed consent
- •Severe hearing or visual impairment preventing reliable CAM assessment
- •Contraindications to regional anesthesia (e.g., coagulopathy according to institutional standards, infection at the injection site, allergy to local anesthetics)
- •Pre-existing neurological deficits of the operative lower limb are interfering with assessment
- •Chronic opioid use (>30 mg morphine milligram equivalents per day for >2 weeks prior to surgery)
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- •Severe hepatic insufficiency
- •Participation in another interventional clinical trial within 30 days
- •Any other condition that, in the investigator's judgment, may interfere with study participation or protocol adherence
研究组 & 干预措施
Sham Block
PENG block with 20ml of 0.9% sodium chloride
干预措施: sham block with 0.9% sodium chloride (Drug)
PENG block
PENG block with 20ml 0f 0.2% ropivacaine
干预措施: 0.2% ropivacaine (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: 12 hours after surgery
Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no)
次要结局
- Incidence of Postoperative Delirium(24 hours after surgery)
- Incidence of Postoperative Delirium(48 hours after surgery)
- Incidence of Postoperative Delirium(72 hours after surgery)
- Cumulative Postoperative Opioid Consumption (MME)(48 hours after surgery)
- Postoperative Pain Intensity (NRS)(4 hours after surgery)
- Postoperative Pain Intensity (NRS)(8 hours after surgery)
- Postoperative Pain Intensity (NRS)(12 hours after surgery)
- Postoperative Pain Intensity (NRS)(24 hours after surgery)
- Postoperative Pain Intensity (NRS)(48 hours after surgery)
- Postoperative Pain Intensity (NRS)(72 hours after surgery)
- Time to First Rescue Opioid Administration(48 hours after surgery)
- Incidence of Postoperative Nausea and Vomiting (PONV)(24 hours after surgery)
- Time to First Mobilization(72 hours after surgery)
- Systemic Inflammation Response Index (SIRI)(12 hours after surgery)
- Systemic Inflammation Response Index (SIRI)(24 hours after surgery)
- Systemic Inflammation Response Index (SIRI)(48 hours after surgery)
- Systemic Inflammation Response Index (SIRI)(72 hours after surgery)