Evaluation of Postoperative Recovery When Combining Intravenous Lidocaine With Ropivacaine Infiltrations in Colorectal Laparoscopic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Postoperative Quality of Recovery
研究概览
简要总结
This randomized controlled trial evaluates whether perioperative intravenous lidocaine infusion, combined with port-site ropivacaine infiltration, improves postoperative recovery after laparoscopic abdominal surgery. Participants will be assigned 1:1 to receive either intravenous lidocaine during surgery plus ropivacaine infiltration at surgical closure, or ropivacaine infiltration alone. The primary endpoint is postoperative quality of recovery measured by the QoR-15 questionnaire. Secondary endpoints include postoperative pain and opioid consumption, as well as plasma lidocaine and ropivacaine concentrations to assess systemic exposure and safety.
详细描述
Participants will be randomly assigned in a 1:1 ratio to one of two perioperative analgesic strategies:
- Experimental group: intravenous lidocaine infusion during surgery combined with port-site ropivacaine infiltration at surgical closure
- Control group: port-site ropivacaine infiltration alone at surgical closure (standard care) In the experimental arm, lidocaine will be administered at induction of general anesthesia with an intravenous bolus dose of 1.5 mg/kg followed by a continuous infusion of 2 mg/kg/hour. Dosing will be based on actual body weight, with adjustment for patients with obesity (BMI ≥ 30 kg/m²) using adjusted body weight. The infusion will be discontinued at the time of surgical closure, immediately prior to trocar-site infiltration with ropivacaine.
In both groups, trocar/port-site infiltration will be performed by the surgeon at the end of the procedure using ropivacaine 2 mg/mL, with a maximum total volume of 20 mL, injected into the deep musculo-aponeurotic layers of trocar incisions.
All participants will receive standardized general anesthesia and a multimodal postoperative analgesia regimen according to institutional protocols, including scheduled non-opioid analgesics and rescue opioids as needed based on pain intensity.
To assess systemic exposure and safety, plasma concentrations of lidocaine will be measured at predefined time points: 30 minutes after initiation of infusion, at surgical closure, and at 30 minutes, 2 hours, and 6 hours postoperatively. Plasma ropivacaine concentrations will also be measured after infiltration (30 minutes, 2 hours, and 6 hours). These measurements will allow evaluation of peak concentrations, variability, and potential accumulation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing scheduled colorectal cancer surgery via laparoscopy.
- •Patient aged 18 years or older.
- •Informed consent obtained and signed.
- •Affiliation to a social security system.
排除标准
- •Allergy or contraindication to lidocaine or ropivacaine.
- •Allergy or contraindication to paracetamol, nefopam ketamine, propofol, dexamethasone, sufentanil, Celebrex or parecoxib, morphine derivatives, and colorectal surgery by laparotomy
- •Colorectal surgery with a non-cancerous indication.
- •Chronic preoperative pain (defined as persistent pain for more than 3 months).
- •Preoperative use of opioids or opioid derivatives.
- •Patients with psychiatric disorders.
- •Patients for whom self-assessment of pain using a self-reported scale cannot be performed (non-communicative, non-French speaking, etc.).
- •Pregnant or breastfeeding women.
- •Patients under guardianship, curatorship, or legal protection.
研究组 & 干预措施
Control Group
Laparoscopic port-site infiltration with Ropivacaine Alone (No IV Lidocaine)
干预措施: Procedure/Standard care (Drug)
Control Group
Laparoscopic port-site infiltration with Ropivacaine Alone (No IV Lidocaine)
干预措施: ropivacaine (Drug)
Experimental group
IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine
干预措施: Procedure/Standard care (Drug)
Experimental group
IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine
干预措施: ropivacaine (Drug)
Experimental group
IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine
干预措施: Lidocaine (intravenous infusion, perioperative) (Drug)
结局指标
主要结局
Postoperative Quality of Recovery
时间窗: Postoperative day 1 (within 24 hours after surgery)
Quality of postoperative recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15) QoR-15 score is a validated patient-reported outcome measure evaluating comfort, pain, emotional state, physical independence, and overall well-being. Higher scores indicate better recovery.
次要结局
- Plasma lidocaine concentrations(day 0)
- Plasma ropivacaine concentrations(30 minutes after port-site infiltration)
- plasmatic accumulation of lidocaine levels(at 30 minutes)
- Plasma lidocaine concentrations(30 minutes after initiation of infusion)
- Plasma lidocaine concentrations(30 minutes after surgery)
- Plasma lidocaine concentrations(2 hours after surgery)
- Plasma lidocaine concentrations(6 hours after surgery)
- Proportion of patients exceeding predefined safety plasma thresholds(Up to 6 hours postoperatively)
- Postoperative nausea and vomiting (PONV)(Up to 24 hours postoperatively)
- Plasma ropivacaine concentrations(2 hours after port-site infiltration)
- Plasma ropivacaine concentrations(6 hours after port-site infiltration)
- Incidence of local anesthetic systemic toxicity (LAST) or adverse events(From induction of anesthesia up to 24 hours postoperatively)
- Length of postoperative hospital stay(From surgery until hospital discharge (up to 30 days))
- Postoperative pain intensity(Up to 48 hours postoperatively)
- Postoperative opioid consumption(From induction of anesthesia up to 24 hours postoperatively)
- Maximum postoperative pain intensity(Up to 48 hours postoperatively)
- Postoperative analgesic consumption(Up to 48 hours postoperatively)
- Incidence of sensory disturbances at the surgical site(48 hours postoperatively)
- Incidence of neuropathic pain(48 hours postoperatively)
- Incidence of neuropathic pain(3 months postoperatively)
- Time to recovery of bowel function(up to 30 days)
- Patient satisfaction (EVAN-G score)(up to 30 days)
- surgical complications(at 1 month)
- Number of patients with postoperative chemotherapy(up to 30 days)
- length of hospital stay(up to 30 days)