Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Procedure/Standard care, ropivacaine, Lidocaine (intravenous infusion, perioperative).
- Кому может быть актуально
- Состояния в реестре: Intravenous Lidocaine, Laparoscopic Surgery, Post Operative Recovery, Local Anaesthetic Systemic Toxicity. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Postoperative Recovery When Combining Intravenous Lidocaine With Ropivacaine Infiltrations in Colorectal Laparoscopic Surgery
Обзор
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.
Подробное описание
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.
The primary objective of the study is to determine whether the addition of perioperative intravenous lidocaine improves postoperative quality of recovery, assessed using the QoR-15 questionnaire at the predefined postoperative time point(s) specified in the protocol.
Secondary objectives include evaluation of postoperative pain intensity, opioid consumption, and other recovery-related outcomes. In addition, to characterize systemic exposure and support safety assessment of the combined local anesthetic strategy, 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 be measured after infiltration (30 minutes, 2 hours, and 6 hours). These measurements will allow evaluation of peak concentrations, variability, and potential accumulation relative to predefined safety thresholds.
This trial will provide clinically relevant evidence regarding the impact of perioperative intravenous lidocaine on patient-centered recovery after laparoscopic surgery, while also documenting pharmacokinetic exposure and safety when combined with port-site ropivacaine infiltration.
Вмешательства
- Препарат Procedure/Standard care
* General anesthesia (standardized induction): Propofol 2 mg/kg; Sufentanil 0.2 µg/kg; Ketamine 0.5 mg/kg; Dexamethasone 8 mg; neuromuscular blocker per anesthesiologist; maintenance with halogenated gases * Immediate postoperative analgesia at end of procedure: Paracetamol 1 g; Nefopam (Acupan) 20 mg; Parecoxib 40 mg * Postoperative analgesia regimen: Paracetamol 1 g ×4/day; Celecoxib 100 mg ×2/day; add Nefopam 30 mg ×3/day for moderate pain; morphine (Actiskenan) 5-10 mg every 4-6 h for severe - Препарат ropivacaine
1 Drug: Ropivacaine (laparoscopic port-site infiltration, surgical closure) * Timing: at surgical closure (end of surgery), performed by surgeon * Concentration: 2 mg/mL * Volume: up to 20 mL (maximum) * Technique: deep musculo-aponeurotic layers * Ropivacaine plasma sampling: 30 min, 2 h, and 6 h after infiltration - Препарат Lidocaine (intravenous infusion, perioperative)
* Start: at induction of general anesthesia * Loading dose (bolus): 1.5 mg/kg IV, based on actual body weight * Continuous infusion: 2 mg/kg/hour IV, based on actual body weight; for patients with BMI ≥ 30 kg/m², dosing based on adjusted body weight (Ideal body weight + 0.4 × \[Actual - Ideal\]) * Stop: at surgical closure, at the time of wound infiltration with ropivacaine * Lidocaine plasma sampling (pharmacokinetics/safety): 30 min after start of infusion; at surgical closure; 30 min after cl
Первичные конечные точки
- Postoperative Quality of Recovery [Срок оценки: Postoperative day 1 (within 24 hours after surgery)]
Вторичные конечные точки (12)
- Plasma lidocaine concentrations [Срок оценки: day 0]
- Plasma ropivacaine concentrations [Срок оценки: 30 minutes after port-site infiltration]
- plasmatic accumulation of lidocaine levels [Срок оценки: at 30 minutes]
- Plasma lidocaine concentrations [Срок оценки: 30 minutes after initiation of infusion]
- Plasma lidocaine concentrations [Срок оценки: 30 minutes after surgery]
- Plasma lidocaine concentrations [Срок оценки: 2 hours after surgery]
- Plasma lidocaine concentrations [Срок оценки: 6 hours after surgery]
- Proportion of patients exceeding predefined safety plasma thresholds [Срок оценки: Up to 6 hours postoperatively]
- Postoperative nausea and vomiting (PONV) [Срок оценки: Up to 24 hours postoperatively]
- Plasma ropivacaine concentrations [Срок оценки: 2 hours after port-site infiltration]
- Plasma ropivacaine concentrations [Срок оценки: 6 hours after port-site infiltration]
- Incidence of local anesthetic systemic toxicity (LAST) or adverse events [Срок оценки: From induction of anesthesia up to 24 hours postoperatively]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Франция · 1 центр
- CHU Amiens — Amiens
Идентификаторы
NCT: NCT07414706 · PI2025_843_0004