Clinical trial NCT04969133: TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children
Official title: TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis Acute
Pediatrics
Analgesia
Keywords: Appendicectomy
Laparoscopy
infiltration
TAP block
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: cumulative dose of nalbuphine in the 24 first hours post surgery
timeFrame: 24 hours
Secondary outcomes:
measure: cumulative dose of nalbuphine H0-H12 post surgery
timeFrame: from beginning to 12th hour
measure: cumulative dose of nalbuphine H13-H24 post surgery
timeFrame: From 13th hour to 24th hour
measure: FLACC analgesia score at H1 H2 H6 H12 H24
timeFrame: FLACC score will be performed from awakenig to 24 hours post surgery
measure: FLACC score mean
timeFrame: FLACC score will be performed from awakenig to 24 hours surgery
measure: individual variations of FLACC score
timeFrame: FLACC score will be performed from awakenig to 24 hours surgery
measure: timing of first injection of nalbuphine
timeFrame: in the first 24 post operative hours
measure: incidence of post operative nausea and vomiting
timeFrame: in the first 24 post operative hours
measure: timing of first standing up
timeFrame: in the first 24 post operative hours
measure: adverse events
timeFrame: in the first 24 post operative hours
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besancon
Study officials:
References: