2025-523207-29-00招募中4 期
Evaluation of postoperative recovery when combining intravenous lidocaine with ropivacaine infiltration in laparoscopic colorectal oncologic surgery: a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.
研究概览
简要总结
Evaluate the effectiveness of combining intravenous lidocaine and ropivacaine infiltration of laparoscopic trocar sites on postoperative recovery as assessed using the QOR-15 twenty-four hours after colorectal surgery.
研究设计
- 分配方式
- Randomized
- 主要目的
- Avec Lidocaine Vs Sans Lidocaine
- 盲法
- Single (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 undergoing scheduled laparoscopic colorectal cancer surgery.
- •Patients aged 18 years or older
- •Highly effective method of contraception for women of childbearing age (combined hormonal contraception (estrogen and progesterone) combined with ovulation inhibition (oral, intravaginal, transdermal), hormonal contraception (progesterone only) combined with ovulation inhibition (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral fallopian tube occlusion, vasectomized partner, sexual abstinence.
- •Informed consent and signed agreement
- •Enrollment in a Social Security plan
排除标准
- •Allergy or contraindication to lidocaine or ropivacaine,
- •Patients under guardianship, conservatorship, or legal protection
- •Allergy or contraindication to paracetamol, nefopam, ketamine, propofol, dexamethasone, sufentanil , Celebrex or Parecoxib, , morphine derivatives, and Colorectal surgery by laparotomy
- •Colorectal surgery by laparotomy
- •Colorectal surgery not indicated for cancer treatment
- •Chronic preoperative pain (defined as pain persisting for more than 3 months),
- •Preoperative use of opioids or opioid derivatives,
- •Patients suffering from psychiatric disorders
- •Patients for whom pain self-assessment using a self-assessment scale cannot be performed (non-communicative, non-English-speaking, etc.)
- •Pregnant or breastfeeding women
结局指标
主要结局
Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.
Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.
次要结局
- Assessment of plasma concentrations of lidocaine (toxic threshold >5 µg/mL) and ropivacaine (toxic threshold >2.2 µg/mL)
- Signs of local anesthetic toxicity sought in the post-anesthesia care unit (PACU) for up to two hours after the end of the procedure: o Cardiological (conduction disorders, atrioventricular conduction disorders, rhythm disorders, especially ventricular: ventricular tachycardia, ventricular fibrillation, or even cardiac arrest in asystole) o Neurological (perioral tingling, headaches, visual or auditory distortions, tremors in the extremities, loss of consciousness, coma, convulsions)
- Postoperative pain assessed using the numerical rating scale (NRS) at H2 at rest, H24 at rest and during mobilization, H48 at rest and during mobilization
- Maximum pain assessed using the NRS during the first 48 hours
- Postoperative analgesic consumption during the first 48 hours
- Consumption of morphine derivatives expressed in oral morphine equivalent (mg) per operation and 48 hours post-operatively
- Occurrence of dysesthesia (peri-scar hyperalgesia, allodynia, numbness) at the surgical site at 48 hours
- Neuropathic pain, defined as a DN4 score > 4/10 at 48 hours and 3 months
- The time before resumption of transit (resumption of gas and then bowel movements) and food tolerance will be assessed through daily interviews with the physician.
- Medical and surgical complications will be assessed using the Clavien Dindo score one month after surgery.
- Possibility of chemotherapy within two months post-op if indicated by the oncology multidisciplinary team meeting
- Length of stay from admission to discharge, expressed in days
- Patient satisfaction, assessed using the EVANS score upon discharge
研究者
Ottilie Trocheris - Fumery
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (1)
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