Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis

Intravenous administration of lidocaine perioperatively after laparotomy for peritonitis could be an interesting alternative by reducing the duration of postoperative ileus, the intensity of pain and the patient's hospital stay, as well as the cost of management in our context of lack of financial, technical and human resources, hence the present study.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Lidocaine intravenous; Drug: Serum saline intravenous

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertille KI, Doctor; Phone Number: +22670230257; Email: bertilleki@yahoo.fr
• Study Contact Backup: Name: Ismael Guibla, doctor; Phone Number: +22676135113; Email: ismaelguibla@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients aged 6 to 15, Classified according to the American Society of Anaesthesiologists (ASA) (I, II and III) admitted for peritonitis and whose parents have given informed consent

Exclusion Criteria:

• State of shock
• Severe renal insufficiency (creatinine clearance less than 30 ml/min)
• History of allergy to lidocaine
• Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine group; The group will receive 1.5 mg/kg lidocaine 2% bolus, followed by a continuous electric syringe dose of 1.5 mg/kg/hour intraoperatively, then 1.5 mg/kg/hour during the first 24 hours postoperatively	Drug: Lidocaine intravenous; Perioperative lidocaine intravenous administration
Placebo Comparator: Saline group; The control group will receive an equivalent volume of saline: the volume of saline to be administered will be obtained by considering the dose of lidocaine 2% that the patient would have received if he/she had been in the interventional group.	Drug: Serum saline intravenous; Perioperative serum saline intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resumption of transit	time to first gas and/or presence of bowel sounds	Up to 7 days during the postoperative period. From the date of randomization to the first postoperative gas and/or the presence of postoperative bowel sounds in the patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analog visual scale	Average pain score, minimal value is 0, maximal value is 10 and higher score mean worse	Postoperative pain scores at 24 hours
Concentration of C-reactive protein	Average of C-reactive protein	Hours 24 postoperative
Hospitalisation	Number of days in hospital	Up to 30 days during the postoperative period. From the date of randomization to the patient's discharge from hospital or date of death
Postoperative mortality	Number of postoperative deaths	Up to 30 days during the postoperative period. From date of randomization to date of death

Collaborators and Investigators

• Sponsor: Université NAZI BONI
• Investigators: Study Director: Nazinigouba OUEDRAOGO, Professor, JOSEPH KI-ZERBO University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Lidocaine; Postoperative pain; Burkina Faso; Peritonitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Intraabdominal Infections; Pain, Postoperative; Peritonitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: INSSA 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No