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

NCT06051630 | Unknown

• 1 other identifier: INSSA 3
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Peritonitis; Postoperative pain; Lidocaine; Burkina Faso

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analog visual scale

  Postoperative pain scores at 24 hours

• Concentration of C-reactive protein

  Hours 24 postoperative

• Hospitalisation

  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

  Up to 30 days during the postoperative period. From date of randomization to date of death

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Saline group

PLACEBO COMPARATOR

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

Interventions

Lidocaine intravenous DRUG

Perioperative lidocaine intravenous administration

Lidocaine group

Serum saline intravenous DRUG

Perioperative serum saline intravenous administration

Saline group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Université NAZI BONI: lead

MeSH Terms

Conditions

Pain, Postoperative; Peritonitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Nazinigouba OUEDRAOGO, Professor

  JOSEPH KI-ZERBO University

  STUDY DIRECTOR

Central Study Contacts

Bertille KI, Doctor

CONTACT

+22670230257; bertilleki@yahoo.fr

Ismael GUIBLA, Doctor

CONTACT

+22676135113; ismaelguibla@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Clinical doctor

Model Details: This will be a randomized, double-blind clinical trial conducted at University hospital Charles De Gaulle of Ouagadougou, comparing the results of intravenous administration of lidocaine perioperatively versus administration of saline

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 25, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share