Comparison of Postoperative Analgesic Effects of Two Different Anesthesia Techniques in Knee Arthroplasty: Nerve Blocks Named BiFeS and iPACK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Postoperative 12th hour pain score
研究概览
简要总结
The Biceps Femoris Short Head (BiFeS) block is a new fascial plane block technique targeting the sensory innervation of the posterolateral capsule of the knee while preserving motor function. The aim of this study is to evaluate the postoperative analgesic efficacy of the BiFeS block combined with the adductor canal block (ACB) in patients undergoing total knee arthroplasty, compared to ACB + iPACK block. The study is planned as a prospective, randomized, double-blind, parallel two-group trial. Patients will be randomized in a 1:1 ratio to receive ACB + iPACK (Group A) or ACB + BiFeS (Group B). Postoperative pain scores (VAS), opioid consumption, early mobilization, and quality of recovery (QoR-15) outcomes will be compared.
详细描述
Total knee arthroplasty (TKA) is an effective surgical method for the treatment of advanced osteoarthritis, reducing pain and improving functional capacity. However, approximately 30-40% of cases experience severe postoperative pain, and 20-31% of patients develop persistent postoperative pain (1, 2). This not only delays early mobilization and rehabilitation but also negatively affects patient satisfaction and overall recovery.
Enhanced Recovery After Surgery (ERAS) protocols emphasize that effective postoperative analgesia is indispensable for early mobilization and functional recovery. Multimodal analgesic strategies, particularly combinations of motor-sparing regional anesthesia techniques, are a cornerstone of these protocols (3).
One of these regional anesthesia techniques, the femoral nerve block (FNB), provides strong analgesic efficacy but reduces quadriceps strength, increasing the risk of falls. Therefore, in recent years, "motor-sparing" approaches aimed at preserving motor function have gained prominence (4).
Recent high-level network meta-analyses have shown that combinations of motor-sparing regional techniques provide superior outcomes compared to single blocks. In a 2024 meta-analysis by Wang et al., including 30 randomized controlled trials (RCTs), the combination of continuous adductor canal block (cACB) + genicular nerve block (GNB) among motor-sparing approaches provided the lowest rest pain scores at 24 and 48 hours, while cACB + iPACK + GNB combination most effectively reduced pain on movement (5). In the same study, this combination also demonstrated the highest performance in functional recovery indicators, with the shortest Timed-Up-and-Go (TUG) time and greatest range of motion.
Similarly, a 2025 Bayesian network meta-analysis by Migliorini et al., analyzing 77 RCTs, reported the lowest visual analog scale (VAS) scores between postoperative days 1-3 with continuous periarticular analgesia/local infiltration analgesia (PCI/LIA); this was followed by continuous FNB/PCI and continuous ACB applications, respectively (6).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral total knee arthroplasty
- •Classified as ASA physical status I-III
排除标准
- •Scheduled for revision arthroplasty or bilateral surgery
- •Allergy to local anesthetics or contraindication to regional blocks
- •Neurological disorders, peripheral neuropathy, or conditions affecting lower extremity muscle strength
- •Coagulopathy or receiving anticoagulant therapy
- •History of severe liver, kidney, or heart failure
- •Chronic opioid use or history of substance abuse
- •Patients experiencing intraoperative complications (e.g., excessive bleeding)
- •Cases in which adequate sensory blockade is not achieved after the block
研究组 & 干预措施
Adductor Canal(ACB) + iPACK block
干预措施: Infiltration Between The Popliteal Artery and The Capsule of The Knee (Procedure)
Adductor Canal(ACB) + iPACK block
干预措施: Adductor Canal Block (Procedure)
Adductor Canal(ACB) + BiFeS block
干预措施: Biceps Femoris Short Head Block (BiFeS) (Procedure)
Adductor Canal(ACB) + BiFeS block
干预措施: Adductor Canal Block (Procedure)
结局指标
主要结局
Postoperative 12th hour pain score
时间窗: Postoperative 12th hour
Postoperative 12th hour pain score (will be evaluated with Visuel Analog Scale) Higher scores indicate worse condition
次要结局
- Postoperative Rest and Movement VAS Scores at 2, 4, 6, 8, 12, 24, 48, 72 Hours and 1, 3 Months(Postoperative 1st, 2nd, 4th, 8th, 12th, 16th, 24th, 48th hours and 1st ,3th Months)
- Time to Postoperative Rescue Analgesia (minutes)(Postoperative 72th hours)
- Postoperative Cumulative Tramadol Consumption (mg)(Postoperative 72th hours)
- Postoperative Complications such as Nausea and Vomiting(Every 12 hours during the first 72hours postoperative hours)
- Quality of Recovery-15 (QoR-15) Score(preoperative day 1 and postoperative day 1)
- Time to Meet Physiotherapy Criteria for Hospital Discharge(Every 12 hours during the first 72hours postoperative hours)
研究者
Bülent Meriç Çam
Specialist Physician
Amasya University