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

NCT07414706 | Not Yet Recruiting Phase 3

• 1 other identifier: PI2025_843_0004
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intravenous lidocaine; laparoscopic surgery; post operative recovery; local anaesthetic systemic toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Plasma lidocaine concentrations

  day 0

• Plasma ropivacaine concentrations

  30 minutes after port-site infiltration

• plasmatic accumulation of lidocaine levels

  at 30 minutes

• Plasma lidocaine concentrations

  30 minutes after initiation of infusion

• Plasma lidocaine concentrations

  30 minutes after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Drug: Procedure/Standard care; Drug: ropivacaine

Experimental group

EXPERIMENTAL

IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine

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

Interventions

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)

Control Group; Experimental group

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

Control Group; Experimental group

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Interventions

Standard of Care; Ropivacaine; Lidocaine; Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Central Study Contacts

Ottilie Trocheris - Fumery, MD

CONTACT

33+322089108; fumery.ottilie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)