Postoperative Analgesic Efficacy of Ultrasound Guided Para-sartorial Compartments (PASC) Block Versus Combined Femoral-Sciatic Nerve Block in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Total Rescue Analgesia Requirement (Nalbuphine)
研究概览
简要总结
This randomized, double-blind comparative study evaluates postoperative analgesic efficacy and motor effects of ultrasound-guided para-sartorial compartments (PASC) block versus ultrasound-guided combined femoral-sciatic nerve block in patients undergoing total knee arthroplasty. The primary endpoint is total nalbuphine rescue analgesia consumption in the first 24 postoperative hours. Secondary endpoints include pain scores (NRS), motor function using a modified Bromage scale, block performance characteristics, and complications.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are unaware of group assignment. Outcome data are collected by an anesthesiologist blinded to the performed block technique. The anesthesiologist performing the block is not involved in postoperative assessments.
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 to 70 years
- •Scheduled for elective total knee arthroplasty under general anesthesia
- •American Society of Anesthesiologists physical status class I or II
- •Provided written informed consent
排除标准
- •American Society of Anesthesiologists physical status class III or IV
- •Pre-existing neurological abnormality of the lower extremity
- •Infection near the planned block site
- •History of psychiatric illness
- •History of drug abuse
- •Known allergy to local anesthetics or any study medications (bupivacaine, acetaminophen, ketorolac, nalbuphine)
研究组 & 干预措施
Femoral Nerve Block plus Sciatic Nerve Block
After induction of general anesthesia, participants receive an ultrasound-guided single-shot femoral nerve block with 15 milliliters of 0.25% bupivacaine and an ultrasound-guided single-shot popliteal sciatic nerve block with 15 milliliters of 0.25% bupivacaine. Postoperative multimodal analgesia includes intravenous acetaminophen and ketorolac. Rescue analgesia is intravenous nalbuphine 5 milligrams when the Numeric Rating Scale pain score is 3 or higher, up to 20 milligrams per day.
干预措施: Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block (Procedure)
Para-sartorial Compartments Block
After induction of general anesthesia, participants receive an ultrasound-guided single-shot para-sartorial compartments block using a single needle entry point with three injections of 0.25% bupivacaine: 10 milliliters inside the femoral triangle with periarterial and subsartorial spread, 10 milliliters in the subsartorial plane at the apex of the femoral triangle between sartorius and vastus medialis muscles, and 10 milliliters in the suprasartorial compartment at the level of the intermediate femoral cutaneous nerve (total 30 milliliters). Postoperative multimodal analgesia includes intravenous acetaminophen and ketorolac. Rescue analgesia is intravenous nalbuphine 5 milligrams when the Numeric Rating Scale pain score is 3 or higher, up to 20 milligrams per day.
干预措施: Ultrasound-Guided Para-sartorial Compartments Block (Procedure)
结局指标
主要结局
Total Rescue Analgesia Requirement (Nalbuphine)
时间窗: First 24 hours after surgery.
Total dose of intravenous nalbuphine (in milligrams) administered as rescue analgesia when the Numeric Rating Scale pain score is 3 or higher, with a maximum daily dose of 20 milligrams.
次要结局
- Block Performance Time(During block performance immediately after induction of general anesthesia.)
- Block Duration(Up to 24 hours after surgery.)
- Postoperative Pain Intensity (Numeric Rating Scale)(30 minutes after admission to the post-anesthesia care unit, and 3 hours, 6 hours, 12 hours, and 24 hours after surgery.)
- Motor Block Assessment (Modified Bromage Scale)(2 hours, 4 hours, 6 hours, 12 hours, 18 hours, and 24 hours after surgery.)
- Postoperative Nausea(First 24 hours after surgery.)
- Postoperative Vomiting(First 24 hours after surgery.)
- Sedation (Richmond Agitation-Sedation Scale)(First 24 hours after surgery.)
研究者
Mahmoud Mohammed Elsayed Seif
Resident of Anesthesia, Intensive Care and Pain Management
Ain Shams University