ANHYDROUS LIDOCAINE HYDROCHLORIDE for Colorectal cancer

Stratification factors

• Location of surgery (colorectal vs colic alone)

Inclusion criteria

• {"criterion_text":"-Patients undergoing scheduled laparoscopic colorectal cancer surgery."}
• {"criterion_text":"-Patients aged 18 years or older"}
• {"criterion_text":"-Highly effective method of contraception for women of childbearing age (combined hormonal contraception (estrogen and progesterone) combined with ovulation inhibition (oral, intravaginal, transdermal), hormonal contraception (progesterone only) combined with ovulation inhibition (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral fallopian tube occlusion, vasectomized partner, sexual abstinence."}
• {"criterion_text":"-Informed consent and signed agreement"}
• {"criterion_text":"-Enrollment in a Social Security plan"}

Exclusion criteria

• {"criterion_text":"-Allergy or contraindication to lidocaine or ropivacaine,"}
• {"criterion_text":"-Patients under guardianship, conservatorship, or legal protection"}
• {"criterion_text":"-Allergy or contraindication to paracetamol, nefopam, ketamine, propofol, dexamethasone, sufentanil , Celebrex or Parecoxib, , morphine derivatives, and Colorectal surgery by laparotomy"}
• {"criterion_text":"-Colorectal surgery by laparotomy"}
• {"criterion_text":"-Colorectal surgery not indicated for cancer treatment"}
• {"criterion_text":"-Chronic preoperative pain (defined as pain persisting for more than 3 months),"}
• {"criterion_text":"-Preoperative use of opioids or opioid derivatives,"}
• {"criterion_text":"-Patients suffering from psychiatric disorders"}
• {"criterion_text":"-Patients for whom pain self-assessment using a self-assessment scale cannot be performed (non-communicative, non-English-speaking, etc.)"}
• {"criterion_text":"-Pregnant or breastfeeding women"}

Primary endpoints

• {"endpoint_text":"-Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.","definition_or_measurement_approach":"Assessed using the QOR-15 (Quality of Recovery-15) scale at 24 hours after surgery."}

Secondary endpoints

• {"endpoint_text":"-Assessment of plasma concentrations of lidocaine (toxic threshold >5 µg/mL) and ropivacaine (toxic threshold >2.2 µg/mL)","definition_or_measurement_approach":"Measurement of plasma concentrations of lidocaine and ropivacaine; toxic thresholds specified (>5 µg/mL for lidocaine; >2.2 µg/mL for ropivacaine)."}
• {"endpoint_text":"-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\tCardiological (conduction disorders, atrioventricular conduction disorders, rhythm disorders, especially ventricular: ventricular tachycardia, ventricular fibrillation, or even cardiac arrest in asystole) o\tNeurological (perioral tingling, headaches, visual or auditory distortions, tremors in the extremities, loss of consciousness, coma, convulsions)","definition_or_measurement_approach":"Clinical monitoring in PACU up to 2 hours post-procedure for specified cardiological and neurological signs of local anesthetic toxicity."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"Pain measured by Numerical Rating Scale (NRS) at H2 (rest), H24 (rest and mobilization), and H48 (rest and mobilization)."}
• {"endpoint_text":"-Maximum pain assessed using the NRS during the first 48 hours","definition_or_measurement_approach":"Maximum NRS score recorded during first 48 hours postoperatively."}
• {"endpoint_text":"-Postoperative analgesic consumption during the first 48 hours","definition_or_measurement_approach":"Recording of all analgesic consumption in the first 48 hours postoperatively."}
• {"endpoint_text":"-Consumption of morphine derivatives expressed in oral morphine equivalent (mg) per operation and 48 hours post-operatively","definition_or_measurement_approach":"Quantity of morphine derivatives converted to oral morphine equivalent (mg) intraoperatively and at 48 hours post-op."}
• {"endpoint_text":"-Occurrence of dysesthesia (peri-scar hyperalgesia, allodynia, numbness) at the surgical site at 48 hours","definition_or_measurement_approach":"Clinical assessment of dysesthesia (peri-scar hyperalgesia, allodynia, numbness) at 48 hours."}
• {"endpoint_text":"-Neuropathic pain, defined as a DN4 score > 4/10 at 48 hours and 3 months","definition_or_measurement_approach":"Assessment using DN4 questionnaire; neuropathic pain defined as DN4 > 4/10 at 48 hours and at 3 months."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Daily physician interview to determine time to resumption of gas and bowel movements and assess food tolerance."}
• {"endpoint_text":"-Medical and surgical complications will be assessed using the Clavien Dindo score one month after surgery.","definition_or_measurement_approach":"Assessment of complications at 1 month post-op using Clavien-Dindo scoring system."}
• {"endpoint_text":"-Possibility of chemotherapy within two months post-op if indicated by the oncology multidisciplinary team meeting","definition_or_measurement_approach":"Determination of whether patient is able to receive postoperative chemotherapy within 2 months if indicated by the oncology multidisciplinary team."}
• {"endpoint_text":"-Length of stay from admission to discharge, expressed in days","definition_or_measurement_approach":"Calculation of hospital length of stay in days from admission to discharge."}
• {"endpoint_text":"-Patient satisfaction, assessed using the EVANS score upon discharge","definition_or_measurement_approach":"Assessment of patient satisfaction at discharge using the EVAN(S) score."}

France

Earliest CTIS Part Ii Submission Date

03-11-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

44

Number Of Sites

1

Number Of Participants

182

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France