NCT05667987

Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is, in a population of patients undergoing ERCP surgery, treated preventively with NSAIDs and divided into two groups according to the absence (group 1) or presence (group 2) of intravenous lidocaine in the general anesthesia protocol. The main objective of this study is to compare the incidence of post-ERCP pancreatitis between the two groups. type of study: clinical trial participant population/health conditions: Patients with ERCP surgery

Detailed description

This is a single-center, prospective, randomized, single-blind study of two parallel groups of patients undergoing ERCP surgery * Group 1 (n=900): General anesthesia without IV lidocaine administration * Group 2 (n=900): General anesthesia with IV lidocaine administration Randomization Patients who have given written informed consent and received confirmation of eligibility will be randomized into the study according to a randomization list. According to the randomization, patients will be divided into two equal groups of 900 patients (anesthesia with and without lidocaine). The randomization list will be established by a centralized computer procedure. PAP prevention protocols Treatment with indomethacin (100mg intrarectally), which is the reference preventive treatment, will be administered systematically in both groups just before anesthesia (or during anesthesia if ERCP is preceded by an echo-endoscopy). The endoscopic techniques to prevent PAP (pancreatic prosthesis, double guide wire technique, infundibulotomy, needle pre-cutting ...) will be used by the operator according to his procedural habits and will be reported in the CRF. Anesthesia protocol All patients will be operated under general anesthesia with orotracheal intubation without premedication with the same anesthesia protocol: At induction: a hypnotic (propofol or hypnomidate) combined with a morphine (sufentanil or remifentanyl) and low doses of Ketamine and midazolam, with or without curarization. In maintenance phase sevoflurane. Blood pressure will be maintained by administration of ephedrine, neosynephrine or baby noradrenaline. The patient's hydration will be ensured by an infusion of Ringer Lactate (20ml/Kg). In the postoperative period, analgesic treatment will be systematically administered with, according to the needs, palliative analgesics 1 or 2 or morphine titration. Lidocaine administration protocol Patients randomized in group 2 will receive during anesthesia a treatment with 1% non-adrenalized Lidocaine. An initial bolus (1.5mg/kg) will be administered at induction of anesthesia (or upon ERCP decision if echo-endoscopy is in progress). Then IVSE of lidocaine at 2mg/Kg/hr will be started for one hour (to be continued in the ICU if needed).

Conditions

• ERCP Surgery

Interventions

Type	Name	Description
DRUG	Intravenous lidocaine administration	General anesthesia with intravenous lidocaine administration

Timeline

• Start date: 2024-01-18
• Primary completion: 2026-01-18
• Completion: 2026-02-28
• First posted: 2022-12-29
• Last updated: 2025-12-03

Locations

1 site across 1 country: France