2025-523327-21-00招募中4 期
TRAMORNOT: Tramadol versus morphine in postoperative analgesia after laparoscopic abdominal surgery: a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.
研究概览
简要总结
The primary objective of this randomized controlled trial is to compare the quality of recovery at 24 hours postoperatively, assessed using the QoR-15 (Quality of Recovery-15) score, in patients receiving multimodal analgesia with either tramadol or morphine during scheduled major laparoscopic abdominal surgery
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
- •Age ≥18 years
- •Scheduled laparoscopic abdominal surgery with an expected operative duration of 2 hours or more
- •Affiliation to the national health insurance system
- •Signed informed consent to participate in the study
排除标准
- •Allergy or intolerance to any of the following medications: paracetamol, nefopam, ketoprofen, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
- •Patient unable to self-assess pain using a numerical rating scale (0–10) (e.g., due to language barrier)
- •Pregnant or breastfeeding women
- •Patient under legal guardianship, legal protection, or deprived of liberty
- •Contraindication to any of these medications (refer to the Summary of Product Characteristics): paracetamol, ketoprofen, nefopam, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
- •Chronic use of monoamine oxidase inhibitors or CYP2D6 inhibitors
- •Chronic preoperative use of level 2 or 3 analgesics
- •Outpatient surgery
- •Surgery requiring postoperative admission to an intensive care unit (ICU)
- •Patient on long-term oxygen therapy
- •Patient with psychiatric disorders
- •Patient with neurodegenerative diseases
结局指标
主要结局
The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.
The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.
次要结局
- QoR-15 questionnaire scores at 48 and 72 hours
- Mean postoperative pain NRS (0–10) scores in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours
- Opioid consumption expressed in oral morphine equivalent at 24 and 72 hours postoperatively
- Analgesic efficacy after opioid administration, assessed by NRS (0–10) two hours post opioid administration
- Length of stay in the PACU (minutes) and total postoperative hospital stay (days)
- Occurrence of the following adverse effects after opioid use: nausea/vomiting, ileus, hypoxemia, pruritus, confusion (assessed by CAM tool)
- Pain management satisfaction score, evaluated on a numerical scale from 0 to 10 (0 = total dissatisfaction, 10 = total satisfaction) at hospital discharge
- Number of patients consuming opioids daily at 1 and 3 months post-discharge
- Misuse risk assessment using the POMI-5F scale
- Presence of chronic post-surgical pain at 3 months after surgery
研究者
Justine ROUSSEAUX
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (1)
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