Intravenous LidocainePhase 3LivQorNCT07414706
Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
A Phase 3 study testing ropivacaine and Lidocaine (intravenous infusion, perioperative) in people with Intravenous Lidocaine and Laparoscopic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
This randomized controlled trial evaluates whether perioperative intravenous lidocaine infusion, combined with port-site ropivacaine infiltration, improves postoperative recovery after laparoscopic abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Lidocaine, Laparoscopic Surgery, Post Operative Recovery
- What is being tested?
- ropivacaine and Lidocaine (intravenous infusion, perioperative)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2026to Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Ottilie FUMERY- TROCHERIS, MD, fumery.ottilie@chu-amiens.fr
Bruno De Broca, MD
About this study
Official title: Evaluation of Postoperative Recovery When Combining Intravenous Lidocaine With Ropivacaine Infiltrations in Colorectal Laparoscopic Surgery
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.
Read the detailed description
Participants will be randomly assigned in a 1:1 ratio to one of two perioperative analgesic strategies:
- Experimental group: intravenous lidocaine infusion during surgery combined with port-site ropivacaine infiltration at surgical closure
- Control group: port-site ropivacaine infiltration alone at surgical closure (standard care) In the experimental arm, lidocaine will be administered at induction of general anesthesia with an intravenous bolus dose of 1.5 mg/kg followed by a continuous infusion of 2 mg/kg/hour. Dosing will be based on actual body weight, with adjustment for patients with obesity (BMI ≥ 30 kg/m²) using adjusted body weight. The infusion will be discontinued at the time of surgical closure, immediately prior to trocar-site infiltration with ropivacaine.
In both groups, trocar/port-site infiltration will be performed by the surgeon at the end of the procedure using ropivacaine 2 mg/mL, with a maximum total volume of 20 mL, injected into the deep musculo-aponeurotic layers of trocar incisions.
All participants will receive standardized general anesthesia and a multimodal postoperative analgesia regimen according to institutional protocols, including scheduled non-opioid analgesics and rescue opioids as needed based on pain intensity.
To assess systemic exposure and safety, plasma concentrations of lidocaine will be measured at predefined time points: 30 minutes after initiation of infusion, at surgical closure, and at 30 minutes, 2 hours, and 6 hours postoperatively. Plasma ropivacaine concentrations will also be measured after infiltration (30 minutes, 2 hours, and 6 hours). These measurements will allow evaluation of peak concentrations, variability, and potential accumulation.
The primary objective of the study is to determine whether the addition of perioperative intravenous lidocaine improves postoperative quality of recovery, assessed using the QoR-15 questionnaire at the predefined postoperative time point(s) specified in the protocol.
Secondary objectives include evaluation of postoperative pain intensity, opioid consumption, and other recovery-related outcomes. In addition, to characterize systemic exposure and support safety assessment of the combined local anesthetic strategy, plasma concentrations of lidocaine will be measured at predefined time points (30 minutes after initiation of infusion, at surgical closure, and at 30 minutes, 2 hours, and 6 hours postoperatively). Plasma ropivacaine concentrations will be measured after infiltration (30 minutes, 2 hours, and 6 hours). These measurements will allow evaluation of peak concentrations, variability, and potential accumulation relative to predefined safety thresholds.
This trial will provide clinically relevant evidence regarding the impact of perioperative intravenous lidocaine on patient-centered recovery after laparoscopic surgery, while also documenting pharmacokinetic exposure and safety when combined with port-site ropivacaine infiltration.
- Conditions
- Intravenous Lidocaine, Laparoscopic Surgery, Post Operative Recovery, Local Anaesthetic Systemic Toxicity
- Being tested
- Procedure/Standard care, ropivacaine, Lidocaine (intravenous infusion, perioperative)
- Keywords
- Intravenous lidocaine, laparoscopic surgery, post operative recovery, local anaesthetic systemic toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Standard careDrug
- 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; ketoprofene 40 mg
- Postoperative analgesia regimen: Paracetamol 1 g ×4/day; ketoprofene 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)
ropivacaineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Laparoscopic port-site infiltration with Ropivacaine Alone (No IV Lidocaine) Receives: Drug: Procedure/Standard care; Drug: ropivacaine |
| Experimental group | Experimental | IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine Receives: Drug: Procedure/Standard care; Drug: ropivacaine; Drug: Lidocaine (intravenous infusion, perioperative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1 (within 24 hours after surgery)
Secondary outcomes (25)
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
Measured: day 0
Plasma ropivacaine concentrations
Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine
Measured: 30 minutes after port-site infiltration
plasmatic accumulation of lidocaine levels
Safety of anesthesia combination in terms of accumulation of lidocaine levels .
Measured: at 30 minutes
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
Measured: 30 minutes after initiation of infusion
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
Measured: 30 minutes after surgery
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
Measured: 2 hours after surgery
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
Measured: 6 hours after surgery
Proportion of patients exceeding predefined safety plasma thresholds
The proportion of participants with plasma lidocaine or ropivacaine concentrations above predefined safety thresholds will be evaluated.
Measured: Up to 6 hours postoperatively
Postoperative nausea and vomiting (PONV)
Incidence of postoperative nausea and vomiting will be recorded as part of postoperative recovery assessment.
Measured: Up to 24 hours postoperatively
Plasma ropivacaine concentrations
Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine
Measured: 2 hours after port-site infiltration
Plasma ropivacaine concentrations
Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine
Measured: 6 hours after port-site infiltration
Incidence of local anesthetic systemic toxicity (LAST) or adverse events
Occurrence of clinical signs or symptoms suggestive of local anesthetic systemic toxicity (e.g., neurologic or cardiovascular adverse events) and other perioperative adverse events will be monitored.
Measured: From induction of anesthesia up to 24 hours postoperatively
Length of postoperative hospital stay
Duration of hospitalization following surgery will be recorded as an indicator of recovery and discharge readiness.
Measured: From surgery until hospital discharge (up to 30 days)
Postoperative pain intensity
Postoperative pain intensity (Numeric Rating Scale, NRS) Postoperative pain will be assessed using an 11-point numeric rating scale (0 = no pain, 10 = worst imaginable pain), measured at rest and/or during movement according to institutional practice
Measured: Up to 48 hours postoperatively
Postoperative opioid consumption
Occurrence of clinical signs or symptoms suggestive of local anesthetic systemic toxicity (e.g., neurologic or cardiovascular adverse events) and other perioperative adverse events will be monitored
Measured: From induction of anesthesia up to 24 hours postoperatively
Maximum postoperative pain intensity
Maximum postoperative pain intensity (Numeric Rating Scale, NRS) Description: Maximum postoperative pain intensity assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) during the first 48 hours after surgery.
Measured: Up to 48 hours postoperatively
Postoperative analgesic consumption
Total consumption of postoperative analgesics, including non-opioid and opioid medications (expressed in morphine equivalents when applicable), during the first 48 hours after surgery
Measured: Up to 48 hours postoperatively
Incidence of sensory disturbances at the surgical site
Occurrence of peri-incisional dysesthesia, including hyperalgesia, allodynia, or numbness at the operative site, assessed at 48 hours after surgery.
Measured: 48 hours postoperatively
Incidence of neuropathic pain
Neuropathic pain evaluated using the Douleur Neuropathique en 4 questions (DN4) questionnaire.
DN4 is a questionnaire. Neuropathic pain will be defined as a DN4 score >4/10
Measured: 48 hours postoperatively
Incidence of neuropathic pain
Neuropathic pain evaluated using the Douleur Neuropathique en 4 questions (DN4) questionnaire.
DN4 is a questionanaire with 4 questions; Neuropathic pain will be defined as a DN4 score >4/10
Measured: 3 months postoperatively
Time to recovery of bowel function
Time to return of gastrointestinal transit, including first passage of flatus and first bowel movement, as well as tolerance of oral intake, assessed daily by physician interview
Measured: up to 30 days
Patient satisfaction (EVAN-G score)
Patient satisfaction assessed at discharge using the EVAN-G questionnaire (Evaluation du Vécu de l'ANesthésie Générale), a validated measure of perioperative patient experience.
Measured: up to 30 days
surgical complications
surgical complications using the Clavien-Dindo score during the postoperative consultation (performed 1 month postoperatively)
Measured: at 1 month
Number of patients with postoperative chemotherapy
evaluate whether the patient's overall health allows for postoperative chemotherapy if indicated by the oncological multidisciplinary committee (RCP), following the pathological analysis of the surgical specimen
Measured: up to 30 days
length of hospital stay
length of hospital stay
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start22 Sep 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous LidocaineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414706
- Sponsor's protocol ID
- PI2025_843_0004
- Acronym
- LivQor
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No