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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04969133
Other study ID # 2021/571
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 30, 2021
Est. completion date May 25, 2024

Study information

Verified date March 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Amélie JURINE, Doctor
Phone 0033381669403
Email ajurine@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.


Description:

This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date May 25, 2024
Est. primary completion date December 25, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 15 Years
Eligibility Inclusion Criteria: - Age betwween 3 and 15 years - Weight < or = 50 kg - indicaction of coelioscopic appendicectomy - ASA 1,2 or 3 - consent of the children and the holder of parental autority Exclusion Criteria: - Age<3 years or > 15years or weight > 50kg - refusal of the children and the holder of parental autority - ASA 4 - Peritonitis - Patients with long term morphinic traitment - Epilepsy - Hepato-cellular insuffisiancy - local anesthesia allergy or nalbuphine allergy - coagulation abnomrmality - exclusion of health insurance

Study Design


Intervention

Drug:
Levobupivacaine Hydrochloride 2.5 MG/ML
To compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children

Locations

Country Name City State
France CHU Besancon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative dose of nalbuphine in the 24 first hours post surgery recording in mg/kg 24 hours
Secondary cumulative dose of nalbuphine H0-H12 post surgery recording in mg/kg from beginning to 12th hour
Secondary cumulative dose of nalbuphine H13-H24 post surgery recording in mg/kg From 13th hour to 24th hour
Secondary FLACC analgesia score at H1 H2 H6 H12 H24 Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10 FLACC score will be performed from awakenig to 24 hours post surgery
Secondary FLACC score mean Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10 FLACC score will be performed from awakenig to 24 hours surgery
Secondary individual variations of FLACC score Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10 FLACC score will be performed from awakenig to 24 hours surgery
Secondary timing of first injection of nalbuphine recording date and time of first injection in the first 24 post operative hours
Secondary incidence of post operative nausea and vomiting recording the incidence post operative nausea and vomiting in the first 24 post operative hours
Secondary timing of first standing up recording date and time of first standing up in the first 24 post operative hours
Secondary adverse events adverse event monitoring in the first 24 post operative hours
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