About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Procedure/Standard care
Drug* 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 pain (per numeric pain score thresholds)
ropivacaine
Drug1 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
Lidocaine (intravenous infusion, perioperative)
Drug* 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 closure; 2 h and 6 h postoperatively
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Quality of Recovery
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.
Secondary outcomes
Plasma lidocaine concentrations
Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability
Plasma ropivacaine concentrations
Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine
plasmatic accumulation of lidocaine levels
Safety of anesthesia combination in terms of accumulation of lidocaine levels .
Plasma lidocaine concentrations
Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability
Sponsors and contacts
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