Postoperative PainNCT06051630
Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
A study testing Lidocaine intravenous and Serum saline intravenous in people with Postoperative Pain, run by Université NAZI BONI.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Lidocaine intravenous and Serum saline intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- State of shock
- Severe renal insufficiency (creatinine clearance less than 30 ml/min)
- History of allergy to lidocaine
- Refusal to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Lidocaine intravenous, Serum saline intravenous
- Keywords
- Peritonitis, Postoperative pain, Lidocaine, Burkina Faso
- Medical subject headings
- Pain, Postoperative, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine intravenousDrug
Perioperative lidocaine intravenous administration
Serum saline intravenousDrug
Perioperative serum saline intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Serum saline intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resumption of transit
time to first gas and/or presence of bowel sounds
Measured: 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
Average pain score, minimal value is 0, maximal value is 10 and higher score mean worse
Measured: Postoperative pain scores at 24 hours
Concentration of C-reactive protein
Average of C-reactive protein
Measured: Hours 24 postoperative
Hospitalisation
Number of days in hospital
Measured: 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
Measured: Up to 30 days during the postoperative period. From date of randomization to date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université NAZI BONI
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismael Guibla, Université NAZI BONI
- Investigators
- Nazinigouba OUEDRAOGO, Professor, Study director, JOSEPH KI-ZERBO University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051630
- Sponsor's protocol ID
- INSSA 3
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
- ClinicalTrials.gov ID
- NCT06051630
- Acronym / sponsor ID
- INSSA 3
- Conditions
- Postoperative Pain
- Keywords
- Peritonitis, Postoperative pain, Lidocaine, Burkina Faso
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Université NAZI BONIUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: Lidocaine intravenousThe 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 |
| Saline group | Placebo comparator | Drug: Serum saline intravenousThe 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- State of shock
- Severe renal insufficiency (creatinine clearance less than 30 ml/min)
- History of allergy to lidocaine
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine intravenousPerioperative lidocaine intravenous administration | Drug | Lidocaine group |
| Serum saline intravenousPerioperative serum saline intravenous administration | Drug | Saline group |
Primary outcome
Resumption of transit
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
time to first gas and/or presence of bowel sounds
4 secondary outcomes
Analog visual scale
Time frame: Postoperative pain scores at 24 hours
Concentration of C-reactive protein
Time frame: Hours 24 postoperative
Hospitalisation
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
Time frame: Up to 30 days during the postoperative period. From date of randomization to date of death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazinigouba OUEDRAOGO, Professor study director
JOSEPH KI-ZERBO University
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine intravenous and Serum saline intravenous in people with Postoperative Pain, run by Université NAZI BONI.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertille KI, Doctor (+22670230257, bertilleki@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resumption of transit (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.