An interventional study of Intravenous lidocaine administration in ERCP Surgery, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
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
This is a single-center, prospective, randomized, single-blind study of two parallel groups of patients undergoing ERCP surgery
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).
GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Intravenous lidocaine administration
General anesthesia with intravenous lidocaine administration
Plasma lipase level
A plasma lipase level greater than or equal to 3N, considered to be indicative of a PAP, is the primary endpoint of the study
Time frame: Hour 24
Abdominal pain intensity
Assessment of abdominal pain on a simple numerical scale
Time frame: Hour 24
Pancreatic ultrasound or CT scan data
Pancreatic ultrasound or CT scan data if available
Time frame: Hour 24
Severity of pancreatitis
Severity of pancreatitis according to the ATLANTA 2012 criteria
Time frame: Hour 24
Plan to share: No
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GCS Ramsay Santé pour l'Enseignement et la Recherche