Impacts of Dexmedetomidine as an Adjuvant for Femoral Nerve Block on Functional Recovery in Aged Patients After Total Knee Arthroplasty: a Randomized, Double-blinded, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Quality of life at 3 months after surgery-mental component summary score
研究概览
简要总结
Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after total knee arthroplasty (TKA). Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve functional recovery in aged patients after TKA.
详细描述
Many patients following total knee arthroplasty (TKA) complain moderate to severe postoperative pain. Multimodal analgesia, a combination of different techniques and analgesic agents, plays an increasingly important role to relieve pain after TKA. Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after TKA. But local anesthetics alone often exert limited potency of analgesia and are insufficient to avoid supplemental opioid usage. Dexmedetomidine, a selective alpha 2-adrenergic receptor agonist, is widely used in clinical settings due to its properties of sedation, anxiolysis, analgesia, and sleep promotion. Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve the functional recovery in aged patients after TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years but <90 years;
- •Scheduled to undergo unilateral total knee arthroplasty;
- •Planned to use femoral nerve block and patient-controlled intravenous analgesia (PCIA) for multimodal analgesia.
排除标准
- •Scheduled for bilateral total knee arthroplasty or revision surgery;
- •Contraindications to femoral nerve block;
- •Preoperative history of schizophrenia, myasthenia gravis, inability to communicate because of coma, severe dementia, or language barriers;
- •Preoperative history of hemorrhagic disease or coagulopathy;
- •Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
- •Sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
- •Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery), or American Society of Anesthesiologists physical status >III;
- •Preexistent delirium (diagnosed by Three-Dimensional Confusion Assessment Method);
- •Under treatment with dexmedetomidine or clonidine.
研究组 & 干预措施
Dexmedetomidine group
Patients in the dexmedetomidine group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and 1.0 μg/kg dexmedetomidine, in a total volume of 20 ml. Postoperatively, patient-controlled intravenous analgesia is provided for at least 48 hours. The formula is sufentanil (1.25 μg/ml), diluted with normal saline to 100 ml. 5-HT3 receptor antagonist is added when necessary. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h.
干预措施: Dexmedetomidine (Drug)
Control group
Patients in the control group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and normal saline, in a total volume of 20 ml. Postoperatively, patient-controlled intravenous analgesia is provided for at least 48 hours. The formula is sufentanil (1.25 μg/ml), diluted with normal saline to 100 ml. 5-HT3 receptor antagonist is added when necessary. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h.
干预措施: Placebo (Drug)
结局指标
主要结局
Quality of life at 3 months after surgery-mental component summary score
时间窗: At 3 months after surgery
Quality of life is assessed with 12-item short-form (SF-12, it is summarized into physical and mental component summary scores, each ranges from 0 to 100, with higher scores indicating better quality of life).
次要结局
- Length of stay in hospital after surgery(Up to 30 days after surgery)
- The overall subjective sleep quality at 3 months after surgery(At 3 months after surgery)
- Cognitive function at 3 months after surgery(At 3 months after surgery)
- Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery(Up to 30 days after surgery)
- Event-free survival at 3 months after surgery(At 3 months after surgery)
- Incidence of delirium within the first 3 days after surgery(The first 3 days after surgery)
- Quality of life at 3 months after surgery-physical component summary score(At 3 months after surgery)
- The severity of arthritic symptoms at 3 months after surgery(At 3 months after surgery)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital