Intravenous Lidocaine, Laparoscopic Surgery, Local Anaesthetic Systemic Toxicity, Post Operative Recovery
Conditions
Keywords
Intravenous lidocaine, laparoscopic surgery, post operative recovery, local anaesthetic systemic toxicity
Brief summary
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
* 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)
DRUGropivacaine
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
DRUGLidocaine (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 closure; 2 h and 6 h postoperatively
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Quality of Recovery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma lidocaine concentrations | day 0 | 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 | 30 minutes after port-site infiltration | 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 | at 30 minutes | Safety of anesthesia combination in terms of accumulation of lidocaine levels . |
| Proportion of patients exceeding predefined safety plasma thresholds | Up to 6 hours postoperatively | The proportion of participants with plasma lidocaine or ropivacaine concentrations above predefined safety thresholds will be evaluated. |
| Postoperative nausea and vomiting (PONV) | Up to 24 hours postoperatively | Incidence of postoperative nausea and vomiting will be recorded as part of postoperative recovery assessment. |
| Incidence of local anesthetic systemic toxicity (LAST) or adverse events | From induction of anesthesia up to 24 hours postoperatively | Occurrence of clinical signs or symptoms suggestive of local anesthetic systemic toxicity (e.g., neurologic or cardiovascular adverse events) and other perioperative adverse events will be monitored. |
| Length of postoperative hospital stay | From surgery until hospital discharge (up to 30 days) | Duration of hospitalization following surgery will be recorded as an indicator of recovery and discharge readiness. |
| Postoperative pain intensity | Up to 48 hours postoperatively | Postoperative pain intensity (Numeric Rating Scale, NRS) Postoperative pain will be assessed using an 11-point numeric rating scale (0 = no pain, 10 = worst imaginable pain), measured at rest and/or during movement according to institutional practice |
| Postoperative opioid consumption | From induction of anesthesia up to 24 hours postoperatively | Occurrence of clinical signs or symptoms suggestive of local anesthetic systemic toxicity (e.g., neurologic or cardiovascular adverse events) and other perioperative adverse events will be monitored |
| Maximum postoperative pain intensity | Up to 48 hours postoperatively | Maximum postoperative pain intensity (Numeric Rating Scale, NRS) Description: Maximum postoperative pain intensity assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) during the first 48 hours after surgery. |
| Postoperative analgesic consumption | Up to 48 hours postoperatively | Total consumption of postoperative analgesics, including non-opioid and opioid medications (expressed in morphine equivalents when applicable), during the first 48 hours after surgery |
| Incidence of sensory disturbances at the surgical site | 48 hours postoperatively | Occurrence of peri-incisional dysesthesia, including hyperalgesia, allodynia, or numbness at the operative site, assessed at 48 hours after surgery. |
| Incidence of neuropathic pain | 48 hours postoperatively | Neuropathic pain evaluated using the Douleur Neuropathique en 4 questions (DN4) questionnaire. DN4 is a questionnaire. Neuropathic pain will be defined as a DN4 score \>4/10 |
| Time to recovery of bowel function | up to 30 days | Time to return of gastrointestinal transit, including first passage of flatus and first bowel movement, as well as tolerance of oral intake, assessed daily by physician interview |
| Patient satisfaction (EVAN-G score) | up to 30 days | Patient satisfaction assessed at discharge using the EVAN-G questionnaire (Evaluation du Vécu de l'ANesthésie Générale), a validated measure of perioperative patient experience. |
| surgical complications | at 1 month | surgical complications using the Clavien-Dindo score during the postoperative consultation (performed 1 month postoperatively) |
| Number of patients with postoperative chemotherapy | up to 30 days | evaluate whether the patient's overall health allows for postoperative chemotherapy if indicated by the oncological multidisciplinary committee (RCP), following the pathological analysis of the surgical specimen |
| length of hospital stay | up to 30 days | length of hospital stay |
Countries
France
Contacts
CONTACTOttilie Trocheris - Fumery, MD
Outcome results
None listed