2025-523682-24-00招募中3 期
Evaluation of the efficacy of intravenous lidocaine on chronic postoperative pain in patients requiring emergency abdominal surgery. Randomized, double-blind, controlled, multicenter study – LIDOC-POPEYE.
Centre Hospitalier Universitaire De Nantes6 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 6
- 主要终点
- The inclusion criterion for the study is the proportion of patients with an average pain intensity of ≥ 4/10 in the abdomen during the 7 days prior to assessment, as measured using a Simple Numerical Scale, 6 months after surgery.
研究概览
简要总结
The primary objective of the study is to demonstrate the efficacy of continuous intravenous lidocaine infusion during emergency abdominal surgery on postoperative complications, 6 months after the procedure.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall Trial
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older and under 80 years
- •Emergency or semi-emergency abdominal surgery of the following types: -urological -gastrointestinal -gynecological
- •Open or laparoscopic surgery
- •Estimated duration of surgery ≥ 60 minutes
- •Informed consent for competent patients. Consent from the designated representative, or emergency procedure, followed by obtaining the patient’s consent to continue treatment after surgery
排除标准
- •Use of a regional anesthesia technique via epidural analgesia
- •Pregnancy or breastfeeding. Women of childbearing age will undergo a pregnancy test prior to enrollment. -Porphyria
- •Surgery in Connection with a Transplant
- •Contraindications to lidocaine: § Known hypersensitivity to lidocaine, excipients, or amide-type local anesthetics. § Complete heart block § Hypovolemia - Contraindications to treatment with 0.9% NaCl: § Hyperchloremia § Hypernatremia § Severe cases of fluid overload and water-sodium retention, particularly in cases of decompensated heart failure, decompensated liver failure (edematous-ascitic cirrhosis), preeclampsia/ eclampsia.
- •Patients under legal guardianship, conservatorship, or judicial protection.
- •Uncorrected high-degree atrioventricular block, chronic treatment with Class I antiarrhythmic drugs
- •Shock defined by a systolic blood pressure ≤ 90 mmHg upon admission to the emergency operating room
- •Respiratory failure defined by a respiratory rate > 25 breaths/min and/or a pulse oximetry O₂ saturation < 90% upon admission to the emergency operating room
- •Neurological failure defined by a Glasgow Coma Scale score ≤ 13 upon admission to the emergency operating room
- •Known dementia
- •Active drug users or those undergoing withdrawal, given the significant challenges in managing perioperative analgesia in these patient
研究组 & 干预措施
LIDOCAÏNE KABI 20 mg/mL, solution injectable
Test
干预措施: LIDOCAÏNE KABI 20 mg/mL, solution injectable (Drug)
CHLORURE DE SODIUM PROAMP 0,9 %, solution injectable
Placebo
干预措施: CHLORURE DE SODIUM PROAMP 0,9 %, solution injectable (Drug)
结局指标
主要结局
The inclusion criterion for the study is the proportion of patients with an average pain intensity of ≥ 4/10 in the abdomen during the 7 days prior to assessment, as measured using a Simple Numerical Scale, 6 months after surgery.
The inclusion criterion for the study is the proportion of patients with an average pain intensity of ≥ 4/10 in the abdomen during the 7 days prior to assessment, as measured using a Simple Numerical Scale, 6 months after surgery.
次要结局
- - The Brief Pain Inventory (BPI) scale in its simplified version at 3 and 6 months after randomization o Total score for chronic pain assessment o Pain intensity subdomain o Pain interference subdomain
- - Use of acetaminophen, nonsteroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors (duloxetine, venlafaxine), and gabapentinoids (gabapentin, pregabalin) in the Post- , upon hospital discharge, at 3 months, and at 6 months (prescribed doses).
- - Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 3 and 6 months o Subscores by dimension:
- - Numerical scale assessing pain intensity
- - Mental health regarding anxiety and depression symptoms: Hospital Anxiety and Depression Scale (HADS) at 3 and 6 months o Anxiety & Depression Subscore
- - Efficacy will be assessed based on the patient’s psychosocial profile: sleep disorders , history of anxiety-depressive disorders , presence of chronic pain (e.g., long-term morphine use, fibromyalgia)
- - Tolerance will be assessed by the administration of intravenous lipids in the context of acute intraoperative local anesthetic toxicity (cardiac arrest, unexplained shock, convulsions)
研究者
CINOTTI
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (6)
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