2025-521206-18-00招募中3 期
A phase III, randomized, double-blind study assessing the efficacy and safety of intravenous lidocaine versus placebo in patients receiving intrathecal morphine analgesia in major digestive or abdominal surgery by laparotomy
GCS Ramsay Sante Enseignement Et Recherche1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年6月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Total consumption of morphine received postoperatively from the post-interventional monitoring room to H48 (in mg) in IV by PCA (Patient Controlled Analgesia), and oral dose converted to equivalent IV morphine where appropriate
研究概览
简要总结
To assess the superiority of IV lidocaine combined with morphine rachi anaesthesia compared with placebo combined with morphine rachi anaesthesia, in reducing morphine consumption postoperatively at 48 hours, in patients undergoing major digestive or abdominal surgery under laparotomy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynaecological, oesophageal, gastric, duodenal, small intestine, etc.)
- •Scheduled intervention
- •Patient in agreement with rachi morphine anaesthesia
- •Membership of a social security scheme
- •Signed informed consent
排除标准
- •Emergency surgery
- •Severe liver failure
- •Morphine allergy
- •Allergy to lidocaine
- •Gabapentinoids: pregabalin (Lyrica), gabapentin
- •Patient taking part in another clinical trial, or in a period of exclusion from another clinical trial
- •Inability to understand information relating to the study (for linguistic, psychological or cognitive reasons, or due to a lack of literacy skills)
- •Women who are or may become pregnant (of childbearing age, without effective contraception) or who are breast-feeding
- •Patient deprived of liberty or under guardianship or unable to give consent
- •Rhythm disorder at risk of sudden death (e.g. Brugada syndrome)
- •Flecaine as usual treatment
- •Chronic pain with level II or III analgesics
- •Contraindication to non-steroidal anti-inflammatory drugs: history of peptic ulcer disease, stage 3 A renal failure or more (DFG according to CKD EPI < 60 ml/min).
- •Previous bradycardia and/or known conduction disorder (atrioventricular block) / Pacemaker
- •Unstable coronary
- •Myocardial infarction <6 months
- •Severe cardiocirculatory insufficiency
结局指标
主要结局
Total consumption of morphine received postoperatively from the post-interventional monitoring room to H48 (in mg) in IV by PCA (Patient Controlled Analgesia), and oral dose converted to equivalent IV morphine where appropriate
Total consumption of morphine received postoperatively from the post-interventional monitoring room to H48 (in mg) in IV by PCA (Patient Controlled Analgesia), and oral dose converted to equivalent IV morphine where appropriate
次要结局
- Maximum score of the verbal numerical scale (scored from 0 to 10) at rest and during exertion (cough/mobilisation) over the last 12, 24, 48, 72 and 96 hours. The verbal numerical scale was collected every 4 hours after the end of the intervention until H96
- Time between the end of the operation and the first gas described by the patient (in hours)
- Total consumption of IV morphine at H12, H24, H72 and H96 in the 2 groups
- Time of first rise in the 2 groups
- Duration of surgery (in minutes), defined as the time from incision to closure
- Length of hospital stay (in days)
- Morphine-related adverse events by investigator (H0, H12, H24, H48, H72 and H96)
- Lidocaine-related adverse events by investigator (H0 and H12)
- Collection of adverse events in the 2 groups
研究者
Anesthesiologist
Scientific
GCS Ramsay Sante Enseignement Et Recherche
研究点 (1)
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