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NCT Number: NCT07414706

Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80480, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

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

Primary outcomes

  1. Postoperative Quality of Recovery

    Time frame: 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 outcomes

  1. Plasma lidocaine concentrations

    Time frame: 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

  2. Plasma ropivacaine concentrations

    Time frame: 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

  3. plasmatic accumulation of lidocaine levels

    Time frame: at 30 minutes

    Safety of anesthesia combination in terms of accumulation of lidocaine levels .

  4. Plasma lidocaine concentrations

    Time frame: 30 minutes after initiation of infusion

    Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability

  5. Plasma lidocaine concentrations

    Time frame: 30 minutes after surgery

    Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability

  6. Plasma lidocaine concentrations

    Time frame: 2 hours after surgery

    Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability

  7. Plasma lidocaine concentrations

    Time frame: 6 hours after surgery

    Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability

  8. Proportion of patients exceeding predefined safety plasma thresholds

    Time frame: Up to 6 hours postoperatively

    The proportion of participants with plasma lidocaine or ropivacaine concentrations above predefined safety thresholds will be evaluated.

  9. Postoperative nausea and vomiting (PONV)

    Time frame: Up to 24 hours postoperatively

    Incidence of postoperative nausea and vomiting will be recorded as part of postoperative recovery assessment.

  10. Plasma ropivacaine concentrations

    Time frame: 2 hours 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

  11. Plasma ropivacaine concentrations

    Time frame: 6 hours 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

  12. Incidence of local anesthetic systemic toxicity (LAST) or adverse events

    Time frame: 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.

  13. Length of postoperative hospital stay

    Time frame: 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.

  14. Postoperative pain intensity

    Time frame: 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

  15. Postoperative opioid consumption

    Time frame: 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

  16. Maximum postoperative pain intensity

    Time frame: 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.

  17. Postoperative analgesic consumption

    Time frame: 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

  18. Incidence of sensory disturbances at the surgical site

    Time frame: 48 hours postoperatively

    Occurrence of peri-incisional dysesthesia, including hyperalgesia, allodynia, or numbness at the operative site, assessed at 48 hours after surgery.

  19. Incidence of neuropathic pain

    Time frame: 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

  20. Incidence of neuropathic pain

    Time frame: 3 months postoperatively

    Neuropathic pain evaluated using the Douleur Neuropathique en 4 questions (DN4) questionnaire.

    DN4 is a questionanaire with 4 questions; Neuropathic pain will be defined as a DN4 score >4/10

  21. Time to recovery of bowel function

    Time frame: 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

  22. Patient satisfaction (EVAN-G score)

    Time frame: 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.

  23. surgical complications

    Time frame: at 1 month

    surgical complications using the Clavien-Dindo score during the postoperative consultation (performed 1 month postoperatively)

  24. Number of patients with postoperative chemotherapy

    Time frame: 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

  25. length of hospital stay

    Time frame: up to 30 days

    length of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Ottilie Trocheris - Fumery, MD

CONTACT

[email protected]

33+322089108

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Evaluation of Postoperative Recovery When Combining Intravenous Lidocaine With Ropivacaine Infiltrations in Colorectal Laparoscopic Surgery

Acronym: LivQor

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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