Evaluation Of The Efficacy Of A Bolus Infiltration Of The Anaesthetic Tramadol Associated With Continuous Local Anaesthesia Administered Via A Wound Catheter Following Heart Surgery Via Sternotomy At Dijon Chu Single-Centre, Double-Blind, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Consumption of morphine, expressed in milligrams, in the post-operative period
研究概览
简要总结
Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.
The analgesic efficacy of continuous wound infiltration at the sternum following heart surgery has been demonstrated.
The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.
The aim of this study is to determine whether a bolus of tramadol associated with the continuous administration of levobupivacaine via the wound catheter could potentiate the local anaesthetic effects, thus leading to a decreased consumption of postoperative intravenous morphine, and a decrease in morphine-related side effects.
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, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who have provided written consent
- •Patients over 18 years old
- •Patients undergoing heart surgery via sternotomy: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass graft, aorta surgery
- •Patients undergoing emergency or scheduled surgery
排除标准
- •Adults under guardianship
- •Persons without national health insurance cover
- •Pregnant or breast-feeding women
- •Patients already included in the study once
- •Patients with aortic dissection
- •Patients with mediastinitis or sternal nonunion
- •Patients undergoing heart surgery for the second or more time
- •Patients with local infection or generalized bacteraemia-type infection
- •Patients with hypersensitivity to local anaesthetics or to tramadol or to opiates or to one of the excipients present in the products used
- •Patients with hypersensitivity to paracetamol or to paracetamol hydrochloride (prodrug of paracetamol)
- •Patients on antidepressants, gabapentin, pregabalin, neuroleptics
- •Patients with a history of convulsions or epilepsy
- •Patients with preoperative cognitive dysfunction
- •Patients with intracranial hypertension
- •Chronic use of morphines or high-dose steroid or non-steroid anti-inflammatory agents
- •Patients with acute or chronic kidney failure (creatininemia > 170 µmol/L)
- •Patients with liver failure or porphyria
- •Patients under 17 years old
- •Patients with severe respiratory failure
- •Patients treated with a non-selective MAOI (iproniazid), a selective MAOI A (moclobemid, toloxatone), selective MAO-B inhibitor (Selegiline) or linezolid (Zyvoxid®)
- •Patients with acute intoxication or an overdose of products that depress the central nervous system (alcohol, hypnotics, other analgesics…)
- •Patients with severe hypotension
研究组 & 干预措施
Levobupivacaine + tramadol group
干预措施: levobupivacaine (Drug)
Levobupivacaine + tramadol group
干预措施: tramadol (Drug)
Levobupivacaine group
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Consumption of morphine, expressed in milligrams, in the post-operative period
时间窗: 48 hour after extubation
次要结局
未报告次要终点