Postoperative Effects of Femoral Triangle Block Versus Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty Under a Multimodal Analgesia Protocol: A Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Participants with quadriceps functional impairment at 6 hours after block completion
研究概览
简要总结
The goal of this clinical trial is to compare the effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after total knee arthroplasty (TKA).
The main question it aims to answer is whether FTB causes more early quadriceps functional impairment than ACB under a standardized multimodal analgesia protocol.
Researchers will compare FTB and ACB using a composite binary functional outcome measured 6 hours after block completion. Quadriceps functional impairment is defined as the inability to perform a structured straight leg raise or quadriceps muscle strength <50% of the preoperative baseline.
Participants will be randomly assigned to receive ultrasound-guided FTB or ACB. All participants will also receive a popliteal plexus block and standardized multimodal analgesia.
详细描述
This is a single-center, randomized, parallel-group clinical trial designed to compare the postoperative effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after primary unilateral total knee arthroplasty (TKA). A total of 136 adult participants are planned for enrollment at Daiyukai General Hospital.
Participants will be randomly assigned to receive ultrasound-guided FTB or ultrasound-guided ACB as part of a standardized multimodal analgesia protocol. In all participants, a popliteal plexus block will also be performed to standardize posterior knee analgesia.
The primary outcome is quadriceps functional impairment at 6 hours after block completion, assessed using a composite binary functional outcome defined as the inability to perform a structured straight leg raise or normalized isometric quadriceps muscle strength <50% of the preoperative baseline.
Secondary outcomes include quadriceps functional impairment at 24 hours after block completion using the same composite definition, postoperative pain intensity, rescue analgesic consumption, early mobilization and rehabilitation-related measures, active knee range of motion, time to achieve active knee flexion of at least 120 degrees, and ultrasound-assessed local anesthetic spread.
The study aims to determine whether FTB results in greater early motor impairment than ACB under a standardized multimodal analgesia protocol while maintaining clinically appropriate postoperative analgesia.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 20 years of age) are scheduled to undergo primary unilateral TKA.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Ability to ambulate independently prior to surgery.
- •Ability to understand the study procedures and provide written informed consent.
- •Planned perioperative anesthesia management including regional anesthesia as part of standard clinical care.
- •Ability to extend the knee below 30 degrees preoperatively (no knee extension contracture)
排除标准
- •Known allergy or contraindication to local anesthetic agents used in this study.
- •Pre-existing neurological or neuromuscular disorders affect lower limb strength or motor control.
- •Severe cognitive impairment or psychiatric conditions interfere with study participation or assessment.
- •History of revision knee arthroplasty on the operative side.
- •Severe preoperative quadriceps weakness that precludes reliable baseline strength assessment.
- •Any condition deemed by the investigator to make participation inappropriate.
研究组 & 干预措施
Femoral Triangle Block (FTB) Group
Ultrasound-guided femoral triangle block with standardized multimodal analgesia including popliteal plexus block.
干预措施: Femoral Triangle Block (FTB) Group (Procedure)
Adductor Canal Block (ACB) Group
Ultrasound-guided adductor canal block with standardized multimodal analgesia including popliteal plexus block.
干预措施: Adductor Canal Block (ACB) Group (Procedure)
结局指标
主要结局
Participants with quadriceps functional impairment at 6 hours after block completion
时间窗: 6 hours after block completion
Composite binary functional outcome defined as the inability to perform a structured straight leg raise (SLR) or normalized isometric quadriceps muscle strength \<50% of the preoperative baseline. The outcome will be reported as the percentage of participants with quadriceps functional impairment.
次要结局
- Participants with quadriceps functional impairment at 24 hours after block completion(24 hours after block completion)
- Participants able to perform a structured straight leg raise at 6 and 24 hours after block completion(6 and 24 hours after block completion)
- Normalized isometric quadriceps muscle strength at 6 and 24 hours after block completion(6 and 24 hours after block completion)
- Postoperative pain intensity at rest on the Numeric Rating Scale(1, 2, 3, 6, 12, 18, and 24 hours after surgery)
- Postoperative pain intensity during active knee movement on the Numeric Rating Scale(1, 2, 3, 6, 12, 18, and 24 hours after surgery)
- Participants requiring any rescue analgesic during the first 24 postoperative hours(Within the first postoperative 24 hours)
- Number of rescue analgesic administrations during the first 48 postoperative hours(Within the first postoperative 48 hours)
- Time to first mobilization(Within 24 hours after block completion)
- Ability to stand during the first postoperative rehabilitation session(Postoperative day 1)
- Walking distance during routine postoperative rehabilitation(From postoperative days 1 to 7)
- Active knee flexion angle of the operated knee(Postoperative days 1, 2, 3, and 7)
- Active knee extension deficit angle of the operated knee(Postoperative days 1, 2, 3, and 7)
- Time to achieve active knee flexion of at least 120 degrees(Up to postoperative day 7)
- Cranial spread of local anesthetic from the injection point(Immediately after block completion)
- Caudal spread of local anesthetic from the injection point(Immediately after block completion)