drugset / Trial / NCT07414706

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

NCT07414706

Phase 3 Not yet recruiting 182 enrolled Centre Hospitalier Universitaire, Amiens
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-03
Primary completion
2028-06
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 2 mg/kg Intravenous
Subject Ropivacaine Other / unclassified 2 mg/ml Other
Subject Ropivacaine Other / unclassified 20 ml Other
Background Acetaminophen Small molecule 1 g
Background Celecoxib Other / unclassified 100 mg
Background Dexamethasone Small molecule 8 mg
Background Ketamine Small molecule 0.5 mg/kg
Background Morphine Other / unclassified
Background Nefopam Small molecule 20 mg
Background Nefopam Small molecule 30 mg
Background Parecoxib Small molecule 40 mg
Background Propofol Small molecule 2 mg/kg
Background Sufentanil Other / unclassified 0.2 ug/kg