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Recruiting NCT07414706

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

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 182
Sponsor: Centre Hospitalier Universitaire, Amiens

Location: CHU Amiens Amiens

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07414706). StuddyBuddy aggregates publicly available trial information.