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