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Evaluation of postoperative recovery when combining intravenous lidocaine with ropivacaine infiltration in laparoscopic colorectal oncologic surgery: a randomized controlled trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523207-29-00
Acronym
PI2025_843_0004
Enrollment
182
Registered
2025-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer laparoscopic surgery

Brief summary

Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.

Detailed description

Assessment of plasma concentrations of lidocaine (toxic threshold >5 µg/mL) and ropivacaine (toxic threshold >2.2 µg/mL), Signs of local anesthetic toxicity sought in the post-anesthesia care unit (PACU) for up to two hours after the end of the procedure: o Cardiological (conduction disorders, atrioventricular conduction disorders, rhythm disorders, especially ventricular: ventricular tachycardia, ventricular fibrillation, or even cardiac arrest in asystole) o Neurological (perioral tingling, headaches, visual or auditory distortions, tremors in the extremities, loss of consciousness, coma, convulsions), Postoperative pain assessed using the numerical rating scale (NRS) at H2 at rest, H24 at rest and during mobilization, H48 at rest and during mobilization, Maximum pain assessed using the NRS during the first 48 hours, Postoperative analgesic consumption during the first 48 hours, Consumption of morphine derivatives expressed in oral morphine equivalent (mg) per operation and 48 hours post-operatively, Occurrence of dysesthesia (peri-scar hyperalgesia, allodynia, numbness) at the surgical site at 48 hours, Neuropathic pain, defined as a DN4 score > 4/10 at 48 hours and 3 months, The time before resumption of transit (resumption of gas and then bowel movements) and food tolerance will be assessed through daily interviews with the physician., Medical and surgical complications will be assessed using the Clavien Dindo score one month after surgery., Possibility of chemotherapy within two months post-op if indicated by the oncology multidisciplinary team meeting, Length of stay from admission to discharge, expressed in days, Patient satisfaction, assessed using the EVANS score upon discharge

Interventions

DRUGACUPAN
DRUGsolution injectable
DRUGXYLOCARD 20 mg/ml INTRAVEINEUX
DRUGDEXAMETHASONE KRKA 8 mg/2 ml
DRUGNEFOPAM BIOGARAN 20 mg/2 mL
DRUGSUFENTANIL KALCEKS 5 microgrammes/mL
DRUGParecoxib Seacross 40 mg powder for solution for injection
DRUGCELEBREX 100 mg capsule
DRUGACTISKENAN 5 mg
DRUGgélule
DRUGPropofol Kabi 10 mg/ml emulsion for injection or infusion
DRUGKETAMINE G.L. PHARMA 10 mg/mL
DRUGROPIVACAINE B.BRAUN 2 mg/ml

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.

Secondary

MeasureTime frame
Assessment of plasma concentrations of lidocaine (toxic threshold >5 µg/mL) and ropivacaine (toxic threshold >2.2 µg/mL), Signs of local anesthetic toxicity sought in the post-anesthesia care unit (PACU) for up to two hours after the end of the procedure: o Cardiological (conduction disorders, atrioventricular conduction disorders, rhythm disorders, especially ventricular: ventricular tachycardia, ventricular fibrillation, or even cardiac arrest in asystole) o Neurological (perioral tingling, headaches, visual or auditory distortions, tremors in the extremities, loss of consciousness, coma, convulsions), Postoperative pain assessed using the numerical rating scale (NRS) at H2 at rest, H24 at rest and during mobilization, H48 at rest and during mobilization, Maximum pain assessed using the NRS during the first 48 hours, Postoperative analgesic consumption during the first 48 hours, Consumption of morphine derivatives expressed in oral morphine equivalent (mg) per operation and 48 hour

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026