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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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

  • 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

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Experimental groupExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Postoperative day 1 (within 24 hours after surgery)

Secondary outcomes

1

Plasma lidocaine concentrations

Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability

Time frame
day 0
2

Plasma ropivacaine concentrations

Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine

Time frame
30 minutes after port-site infiltration
3

plasmatic accumulation of lidocaine levels

Safety of anesthesia combination in terms of accumulation of lidocaine levels .

Time frame
at 30 minutes
4

Plasma lidocaine concentrations

Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability

Time frame
30 minutes after initiation of infusion

Other outcomes

Sponsors and contacts

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