Comparing Suprainguinal Fascia Iliaca Block Versus Adductor Canal Block for Postoperative Pain Control Following Total Knee Arthroplasty;A Prospective, Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Postoperative Pain Intensity (NRS)
研究概览
简要总结
This study evaluates the analgesic efficacy and motor-sparing properties of ultrasound-guided Suprainguinal Fascia Iliaca Block (S-FIB) compared with Adductor Canal Block (ACB) in patients undergoing primary total knee arthroplasty (TKA). The main hypothesis is that ACB better preserves quadriceps muscle strength, allowing earlier functional mobilization, while providing comparable (non-inferior) analgesia to S-FIB.
详细描述
Total knee arthroplasty is associated with severe postoperative pain requiring effective multimodal analgesia, and regional nerve blocks are integral to Fast-Track / ERAS (Enhanced Recovery After Surgery ) protocols. The Suprainguinal Fascia Iliaca Block (S-FIB) targets the anterior branches of the lumbar plexus (femoral, lateral femoral cutaneous, and obturator nerves) from a single high-volume injection, but proximal femoral spread can produce quadriceps motor weakness. The Adductor Canal Block (ACB) predominantly blocks the saphenous nerve, sparing motor function at the potential expense of less comprehensive analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status I, II, or III
- •Scheduled for elective unilateral primary total knee arthroplasty
- •Able to understand and operate the PCA device
- •Written informed consent provided
排除标准
- •Pre-existing lower-extremity neurological deficit or motor weakness (e.g., severe diabetic neuropathy)
- •Chronic opioid use (>30 mg oral morphine equivalents/day for >3 months)
- •Infection at the block site or systemic sepsis
- •Coagulopathy or bleeding diathesis
- •Allergy to local anesthetics or study medications
- •Revision TKA or bilateral knee procedures
- •Cognitive impairment or inability to perform mobility/pain assessments
研究组 & 干预措施
ACB
Active ultrasound-guided Adductor Canal Block
干预措施: PCA (Drug)
S-FIB
Active ultrasound-guided Suprainguinal Fascia Iliaca Block
干预措施: PCA (Drug)
结局指标
主要结局
Postoperative Pain Intensity (NRS)
时间窗: Postoperative hours 24 hour
Numerical Rating Scale (0-10) at rest and during active knee flexion (30°). Time Frame: Postoperative hours 2, 6, 12, 24, and 48.
次要结局
- Quadriceps Muscle Strength(Postoperative hours 6 and 12.)
- Cumulative Opioid Consumption(24 and 48 hours postoperatively.)
- Time to First Mobilization(Up to 48 hours postoperatively.)
- Quality of Recovery (QoR-15)(Baseline (preoperative) and 24 hours postoperatively.)
研究者
Korgün Ökmen
Principal Investigator.PhD.MD
Bursa Yuksek Ihtisas Training and Research Hospital