TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendic… (NCT04969133) | Clinical Trial Compass
CompletedNot Applicable
TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children
France110 participantsStarted 2021-07-30
Plain-language 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.
Who can participate
Age range
3 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
cumulative dose of nalbuphine in the 24 first hours post surgery
Timeframe: 24 hours
Trial details
NCT IDNCT04969133
SponsorCentre Hospitalier Universitaire de Besancon