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

Centre Hospitalier Universitaire, Amiens

Status and phase: Not yet enrolling; Phase 3

Conditions: Laparoscopic Surgery; Post Operative Recovery; Local Anaesthetic Systemic Toxicity; Intravenous Lidocaine

Treatments: Drug: Procedure/Standard care; Drug: ropivacaine; Drug: Lidocaine (intravenous infusion, perioperative)

Study type: Interventional

Funder types: Other

Identifiers

NCT07414706

PI2025_843_0004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Laparoscopic port-site infiltration with Ropivacaine Alone (No IV Lidocaine)

Treatment:

Drug: ropivacaine

Drug: Procedure/Standard care

Experimental group

Experimental group

Description:

IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine

Treatment:

Drug: Lidocaine (intravenous infusion, perioperative)

Drug: ropivacaine

Drug: Procedure/Standard care