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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Surgery; Post Operative Recovery; Intravenous Lidocaine; Local Anaesthetic Systemic Toxicity
• Intervention / Treatment: Drug: Procedure/Standard care; Drug: ropivacaine; Drug: Lidocaine (intravenous infusion, perioperative)

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.

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ottilie Trocheris - Fumery, MD; Phone Number: 33+322089108; Email: fumery.ottilie@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Laparoscopic port-site infiltration with Ropivacaine Alone (No IV Lidocaine)	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 pain (per numeric pain score thresholds); 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
Experimental: Experimental group; IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine	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 pain (per numeric pain score thresholds); 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 closure; 2 h and 6 h postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative day 1 (within 24 hours after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 0
Plasma ropivacaine concentrations	Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine	30 minutes after port-site infiltration
plasmatic accumulation of lidocaine levels	Safety of anesthesia combination in terms of accumulation of lidocaine levels .	at 30 minutes
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	30 minutes after initiation of infusion
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	30 minutes after surgery
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	2 hours after surgery
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	6 hours after surgery
Proportion of patients exceeding predefined safety plasma thresholds	The proportion of participants with plasma lidocaine or ropivacaine concentrations above predefined safety thresholds will be evaluated.	Up to 6 hours postoperatively
Postoperative nausea and vomiting (PONV)	Incidence of postoperative nausea and vomiting will be recorded as part of postoperative recovery assessment.	Up to 24 hours postoperatively
Plasma ropivacaine concentrations	Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine	2 hours after port-site infiltration
Plasma ropivacaine concentrations	Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine	6 hours after port-site infiltration
Incidence of local anesthetic systemic toxicity (LAST) or adverse events	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.	From induction of anesthesia up to 24 hours postoperatively
Length of postoperative hospital stay	Duration of hospitalization following surgery will be recorded as an indicator of recovery and discharge readiness.	From surgery until hospital discharge (up to 30 days)
Postoperative pain intensity	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	Up to 48 hours postoperatively
Postoperative opioid consumption	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	From induction of anesthesia up to 24 hours postoperatively
Maximum postoperative pain intensity	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.	Up to 48 hours postoperatively
Postoperative analgesic consumption	Total consumption of postoperative analgesics, including non-opioid and opioid medications (expressed in morphine equivalents when applicable), during the first 48 hours after surgery	Up to 48 hours postoperatively
Incidence of sensory disturbances at the surgical site	Occurrence of peri-incisional dysesthesia, including hyperalgesia, allodynia, or numbness at the operative site, assessed at 48 hours after surgery.	48 hours postoperatively
Incidence of neuropathic pain	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	48 hours postoperatively
Incidence of neuropathic pain	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	3 months postoperatively
Time to recovery of bowel function	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	up to 30 days
Patient satisfaction (EVAN-G score)	Patient satisfaction assessed at discharge using the EVAN-G questionnaire (Evaluation du Vécu de l'ANesthésie Générale), a validated measure of perioperative patient experience.	up to 30 days
surgical complications	surgical complications using the Clavien-Dindo score during the postoperative consultation (performed 1 month postoperatively)	at 1 month
Number of patients with postoperative chemotherapy	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	up to 30 days
length of hospital stay	length of hospital stay	up to 30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic surgery; Intravenous lidocaine; post operative recovery; local anaesthetic systemic toxicity
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Organic Chemicals; Therapeutics; Drug Administration Routes; Drug Therapy; Quality of Health Care; Quality Indicators, Health Care; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Administration, Intravenous; Infusions, Parenteral; Ropivacaine; Lidocaine; Standard of Care; Infusions, Intravenous
• Other Study ID Numbers: PI2025_843_0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No