Hydromorphone as an Adjuvant to Ropivacaine for Adductor Canal Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
This study proposes a multimodal analgesia regimen comprising preoperative non-steroidal anti-inflammatory drugs (NSAIDs) for preemptive analgesia, intra-articular injection at the end of surgery, and postoperative adductor canal block. The objective is to observe the analgesic efficacy and duration of hydromorphone combined with ropivacaine in the adductor canal block on resting and movement-related pain in patients following total knee arthroplasty, as well as the time to recovery from motor blockade and the incidence of drug-related adverse events.
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)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III;
- •Undergoing elective unilateral primary total knee arthroplasty (TKA);
- •Implementing the ERAS protocol
- •Body-mass index (BMI) of 18.5-32.0 kg/m²;
- •Provided written informed consent.
排除标准
- •Allergy to amide local anaesthetics or opioids;
- •Chronico or disorder opioid use;
- •Pre-existing central and peripheral nerve injuries；
- •Lower limb muscle weakness
- •Unable to cooperate with VAS pain assessment
- •Contraindications for nerve block include infection at the puncture site.
研究组 & 干预措施
Control Group (Group R)
Ultrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
VAS score
时间窗: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
The co-primary outcomes were the resting and movement (active, 45° knee flexion) VAS scores (0-10) at 4, 8, 12, and 24 h after surgery, each referenced to a pre-operative baseline score.
Visual Analog Scale (VAS) Pain Score
时间窗: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
The co-primary outcomes consisted of resting pain score and dynamic pain score during active 45° knee flexion measured by the Visual Analog Scale (VAS). The scale ranges from a minimum value of 0 points (no pain) to a maximum value of 10 points (the worst imaginable pain); higher scores indicate more severe pain. Assessments were conducted at baseline before surgery, and at 4 hours, 8 hours, 12 hours and 24 hours after surgery.
次要结局
- Postoperative analgesia-related adverse reactions(At 4, 8, 12, and 24 hours postoperatively)
- Quadriceps strength(Preoperatively and at 4, 8, 12, and 24 hours postoperatively)
- Postoperative opioid use(At 4, 8, 12, and 24 hours postoperatively)
研究者
Li Zhao
Principal Investigator
China-Japan Friendship Hospital