An interventional study of Lidocaine intravenous and Serum saline intravenous in Postoperative Pain, sponsored by Université NAZI BONI. Not yet recruiting. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Université NAZI BONI · Not applicable, Interventional, and Other
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 62 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Université NAZI BONI is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 lidocaine intravenous administration
Perioperative serum saline intravenous administration
Resumption of transit
time to first gas and/or presence of bowel sounds
Time frame: 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
Analog visual scale
Average pain score, minimal value is 0, maximal value is 10 and higher score mean worse
Time frame: Postoperative pain scores at 24 hours
Concentration of C-reactive protein
Average of C-reactive protein
Time frame: Hours 24 postoperative
Hospitalisation
Number of days in hospital
Time frame: 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
Time frame: Up to 30 days during the postoperative period. From date of randomization to date of death
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Université NAZI BONI