Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Procedure/Standard care, ropivacaine, Lidocaine (intravenous infusion, perioperative).
- Who it may be relevant to
- Registry conditions: Intravenous Lidocaine, Laparoscopic Surgery, Post Operative Recovery, Local Anaesthetic Systemic Toxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Postoperative Recovery When Combining Intravenous Lidocaine With Ropivacaine Infiltrations in Colorectal Laparoscopic Surgery
Overview
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.
Detailed description
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.
Interventions
- Drug 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 - Drug 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 - Drug 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
Primary outcome measures
- Postoperative Quality of Recovery [Time frame: Postoperative day 1 (within 24 hours after surgery)]
Secondary outcome measures (12)
- Plasma lidocaine concentrations [Time frame: day 0]
- Plasma ropivacaine concentrations [Time frame: 30 minutes after port-site infiltration]
- plasmatic accumulation of lidocaine levels [Time frame: at 30 minutes]
- Plasma lidocaine concentrations [Time frame: 30 minutes after initiation of infusion]
- Plasma lidocaine concentrations [Time frame: 30 minutes after surgery]
- Plasma lidocaine concentrations [Time frame: 2 hours after surgery]
- Plasma lidocaine concentrations [Time frame: 6 hours after surgery]
- Proportion of patients exceeding predefined safety plasma thresholds [Time frame: Up to 6 hours postoperatively]
- Postoperative nausea and vomiting (PONV) [Time frame: Up to 24 hours postoperatively]
- Plasma ropivacaine concentrations [Time frame: 2 hours after port-site infiltration]
- Plasma ropivacaine concentrations [Time frame: 6 hours after port-site infiltration]
- Incidence of local anesthetic systemic toxicity (LAST) or adverse events [Time frame: From induction of anesthesia up to 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT07414706 · PI2025_843_0004