Effectiveness of Adductor Canal Block in Postoperative Co-analgesia for Cardiac Surgery With Saphenous Vein Harvesting
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Leg Pain at Rest
研究概览
简要总结
Adductor Canal Block: Efficacy in Postoperative Pain Management for Cardiac Surgery
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned CABG with unilateral or bilateral great saphenous vein (GSV) harvesting, without concomitant valve surgery
- •Age ≥ 18 years
- •Ability to understand the protocol and provide written informed consent
- •ASA physical status I-IV
排除标准
- •Refusal to participate in the study or inability to provide written informed consent
- •Contraindication to adductor canal block (e.g., local infection, allergy to local anesthetics)
- •Pre-existing chronic pain associated with chronic use of analgesic medications other than acetaminophen
- •Pre-existing peripheral neuropathy affecting the leg
- •Participation in two other interventional studies at the Montreal Heart Institute
- •Endoscopic vein harvesting performed by the surgical team instead of open saphenectomy technique
结局指标
主要结局
Leg Pain at Rest
时间窗: Numeric rating scale (NRS 0-10) will be performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.
The primary outcome will be leg pain at rest, measured using a numeric rating scale (NRS 0-10) at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection. The NRS (Numeric Rating Scale) is a validated and widely used tool for assessing pain intensity in adults, particularly in postoperative and critical care settings. It allows for a simple, reproducible, and easily administered measurement, including during repeated assessments at the patient's bedside. The NRS scale consists of asking the patient to rate their pain on a numeric scale from 0 to 10, where: 0 corresponds to no pain at all 10 corresponds to the worst pain imaginable
次要结局
- Total opioid consumption(The first 48 postoperative hours after procedure)
- Postoperative pain unrelated to the saphenous territory(Numeric rating scale (NRS 0-10) performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.)
- Persistent Postoperative Pain(At 3 and 6 months postoperatively, assessed using the NRS.)
- Overall persistent postoperative pain(At 3 and 6 months postoperatively.)
- Presence of hypoesthesia(Numeric rating scale at 3 and 6 months.)
- Neuropathic characterization(At 48 hours, 3 months, and 6 months.)
- Block safety(Assessed daily during hospitalization until patient is discharge from the hospital (an average of 7 days), up to 60 days.)
- Opioid-related side effects(Each time the patient takes opioids during in the postoperative period until discharge from the hospital (an average of 7 days), up to 60 days.)
- Time to extubation(At extubation)