Comparison of Adductor Canal Block Combined With Sacral Erector Spinae Plane Block Versus Adductor Canal Block Combined With iPACK Block in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Tria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to First Rescue Analgesia
研究概览
简要总结
This study will compare two regional anesthesia strategies for pain management after total knee arthroplasty in adults. Both strategies use an adductor canal block (ACB) to provide analgesia while preserving quadriceps muscle strength. The ACB is then combined with either a sacral erector spinae plane block (S-ESPB) or an iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block to improve posterior knee analgesia.
All patients will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of two groups:
Group 1: ACB combined with a sacral erector spinae plane block (S-ESPB) using 20 mL of 0.2% ropivacaine.
Group 2: ACB combined with an iPACK block using 20 mL of 0.2% ropivacaine. Both techniques aim to provide effective postoperative analgesia while minimizing motor blockade and allowing for early mobilization. It is not known whether combining ACB with S-ESPB or with iPACK provides superior pain control, reduces opioid requirements, or results in better functional recovery after total knee arthroplasty.
The main purpose of this study is to compare the time to first rescue analgesia and overall postoperative pain control between the two regional anesthesia strategies. The study will also evaluate opioid consumption, motor function, functional mobility, side effects, and block-related complications.
We hypothesize that both combinations will provide effective analgesia, but their impact on pain intensity, duration of analgesia, and functional recovery may differ.
详细描述
Total knee arthroplasty (TKA) is associated with significant postoperative pain, which can limit early mobilization, delay rehabilitation, and increase opioid use. Inadequate pain control may lead to complications such as decreased range of motion, prolonged hospitalization, and reduced patient satisfaction. Regional anesthesia techniques are a cornerstone of multimodal analgesia protocols for TKA.
The adductor canal block (ACB) is a motor-sparing technique that targets the saphenous nerve and nerve to vastus medialis while largely preserving quadriceps strength. However, ACB alone may not provide sufficient analgesia for posterior knee structures. To address this limitation, it is often combined with other blocks that target posterior knee innervation.
The iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block is designed to anesthetize the articular branches supplying the posterior capsule of the knee without causing significant motor block. The sacral erector spinae plane block (S-ESPB) is a more proximal truncal block, which may provide analgesia to the posterior knee and surrounding structures through spread of local anesthetic in the fascial planes.
This randomized controlled trial will compare two regional anesthesia strategies in patients undergoing total knee arthroplasty:
Adductor canal block (ACB) combined with sacral erector spinae plane block (S-ESPB).
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)
盲法说明
Study blocks will be performed by an anesthesiologist who is not involved in intraoperative management or postoperative outcome assessment. Study medications and syringes will be prepared by a clinician not involved in patient care. All participants will receive identical appearing syringes, and all blocks will be performed under ultrasound guidance in a standardized fashion. Patients, surgeons, ward staff, investigators, and outcome assessors will remain blinded to group allocation.
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Scheduled for elective unilateral total knee arthroplasty under spinal or general anesthesia
- •ASA physical status I-III
- •Planned use of regional anesthesia with an adductor canal block as part of multimodal analgesia
- •Ability to communicate pain intensity using the NRS scale
- •Written informed consent obtained from the patient
排除标准
- •Refusal or inability to provide informed consent
- •Allergy, intolerance, or contraindication to local anesthetics (ropivacaine)
- •Pre-existing significant neurological deficit or neuropathy in the operative limb
- •Coagulopathy or anticoagulation that contraindicates peripheral nerve blocks (e.g., INR >1.5, platelets <100,000/µL, or therapeutic anticoagulation that cannot be safely paused)
- •Infection at or near the planned needle insertion sites
- •Severe hepatic or renal impairment
- •Chronic opioid therapy (>30 days of daily opioid use before surgery)
- •Cognitive impairment or delirium preventing reliable pain assessment BMI > 40 kg/m² (optional - if chcesz ograniczyć ze względu na trudność USG)
- •Previous knee arthroplasty on the same side or revision TKA (jeśli chcesz tylko primary TKA)
- •Pregnancy or breastfeeding
- •Participation in another interventional clinical trial within 30 days
研究组 & 干预措施
Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB)
Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and a sacral erector spinae plane block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia.
干预措施: Adductor Canal Block (Procedure)
Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB)
Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and a sacral erector spinae plane block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia.
干预措施: Sacral Erector Spinae Plane Block (Procedure)
Adductor Canal Block Plus iPACK Block (ACB + iPACK)
Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and an iPACK block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia.
干预措施: Adductor Canal Block (Procedure)
Adductor Canal Block Plus iPACK Block (ACB + iPACK)
Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and an iPACK block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia.
干预措施: iPACK Block (Procedure)
结局指标
主要结局
Time to First Rescue Analgesia
时间窗: Within 48 hours after surgery.
Time (in hours) from completion of the regional blocks to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).
次要结局
- Pain Intensity at Rest (NRS 0-10)(4 hours after surgery.)
- Pain Intensity at Rest (NRS 0-10)(8 hours after surgery.)
- Pain Intensity at Rest (NRS 0-10)(12 hours after surgery.)
- Pain Intensity at Rest (NRS 0-10)(24 hours after surgery.)
- Pain Intensity During Movement (NRS 0-10)(4 hours after surgery.)
- Pain Intensity During Movement (NRS 0-10)(8 hours after surgery.)
- Pain Intensity During Movement (NRS 0-10)(12 hours after surgery.)
- Pain Intensity During Movement (NRS 0-10)(24 hours after surgery.)
- Motor Function (Quadriceps Strength, MRC Scale)(4 hours after surgery.)
- Motor Function (Quadriceps Strength, MRC Scale)(8 hours after surgery.)
- Motor Function (Quadriceps Strength, MRC Scale)(12 hours after surgery.)
- Motor Function (Quadriceps Strength, MRC Scale)(24 hours after surgery.)
- Pain Intensity at Rest (NRS 0-10)(48 hours after surgery.)
- Pain Intensity During Movement (NRS 0-10)(48 hours after surgery.)
- Total Opioid Consumption(0-48 hours after surgery.)
- Motor Function (Quadriceps Strength, MRC Scale)(48 hours after surgery.)
- Incidence of Postoperative Nausea and Vomiting (PONV)(0-48 hours after surgery.)
- Hemodynamic Adverse Events(From block placement until 24 hours after surgery.)
- Block-Related Adverse Events(From block placement until 30 days after surgery.)