Comparison of the Efficacy and Safety of Three Adjuvant Strategies for ACB and iPACK Blocks in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Total postoperative opioid consumption during the first 48 hours after surgery
研究概览
简要总结
This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine. Patients will be randomized into one of three groups: standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, or ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine added to both regional blocks.
The primary outcome will be total postoperative opioid consumption during the first 48 hours after surgery expressed as intravenous morphine equivalents. Secondary outcomes will include pain intensity at rest and during movement, duration of analgesia, time to first rescue analgesia, quadriceps muscle strength, early mobilization, adverse events, inflammatory markers, and length of hospital stay.
详细描述
Postoperative pain following total knee arthroplasty (TKA) remains a major clinical challenge and may negatively affect early mobilization, rehabilitation, patient satisfaction, and postoperative recovery. Inadequate pain control after TKA is associated with increased opioid consumption and opioid-related adverse events, including nausea, vomiting, sedation, urinary retention, respiratory depression, and postoperative delirium, particularly in elderly patients.
Ultrasound-guided Adductor Canal Block (ACB) combined with iPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block has become an increasingly popular regional anesthesia strategy for TKA because it may provide effective analgesia while preserving quadriceps muscle strength and facilitating early mobilization. The ACB primarily targets the sensory innervation of the anterior and medial aspects of the knee, whereas the iPACK block supplements analgesia of the posterior knee capsule.
Several adjuvant medications have been investigated to prolong the duration and improve the quality of peripheral nerve blocks. Intravenous dexamethasone is widely used as a perioperative analgesic adjunct and may prolong postoperative analgesia while also reducing postoperative nausea and vomiting. Perineural dexmedetomidine has been shown to prolong sensory blockade, improve analgesia quality, and reduce opioid requirements. However, the optimal combination of systemic and perineural adjuvants for ACB and iPACK blocks in TKA remains unclear.
The aim of this prospective randomized controlled trial is to compare three perioperative analgesic strategies in patients undergoing elective primary unilateral total knee arthroplasty under spinal anesthesia:
Standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 60 and 100 years
- •Scheduled for elective primary unilateral total knee arthroplasty
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Ability to understand study procedures and provide written informed consent
- •Eligibility for spinal anesthesia and ultrasound-guided regional anesthesia according to institutional standards
排除标准
- •Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication
- •Contraindications to spinal anesthesia or peripheral nerve blocks
- •Coagulation disorders or anticoagulant therapy preventing safe regional anesthesia
- •Infection at the planned puncture site or systemic infection
- •Severe neurological disorders affecting lower limb sensory or motor function
- •Severe hepatic, renal, or uncontrolled cardiovascular disease
- •Clinically significant bradycardia or advanced atrioventricular conduction abnormalities
- •Chronic opioid use for more than 3 months before surgery
- •Uncontrolled diabetes mellitus or contraindications to dexamethasone administration
- •Inability or refusal to provide written informed consent
结局指标
主要结局
Total postoperative opioid consumption during the first 48 hours after surgery
时间窗: 48 hours after surgery
Total postoperative opioid consumption will be recorded during the first 48 hours after total knee arthroplasty and converted to intravenous morphine milligram equivalents.
次要结局
- Pain intensity at rest(6 hours after surgery)
- Pain intensity at rest(12 hours after surgery)
- Pain intensity at rest(24 hours after surgery)
- Pain intensity at rest(48 hours after surgery)
- Pain intensity during movement assessed using the Numeric Rating Scale(6 hours postoperatively)
- Pain intensity during movement assessed using the Numeric Rating Scale(12 hours postoperatively)
- Pain intensity during movement assessed using the Numeric Rating Scale(24 hours postoperatively)
- Pain intensity during movement assessed using the Numeric Rating Scale(48 hours postoperatively)
- Time to first rescue analgesia(48 hours after surgery)
- Quadriceps muscle strength of the operated limb(6 hours postoperatively)
- Quadriceps muscle strength of the operated limb(12 hours postoperatively)
- Quadriceps muscle strength of the operated limb(24 hours postoperatively)
- Quadriceps muscle strength of the operated limb(48 hours postoperatively)
- Time to first postoperative mobilization(48 hours postoperatively)
- Length of hospital stay(up to 7 days)