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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
110
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
CHU Besancon
Besançon, France
cumulative dose of nalbuphine in the 24 first hours post surgery
recording in mg/kg
Time frame: 24 hours
cumulative dose of nalbuphine H0-H12 post surgery
recording in mg/kg
Time frame: from beginning to 12th hour
cumulative dose of nalbuphine H13-H24 post surgery
recording in mg/kg
Time frame: From 13th hour to 24th hour
FLACC analgesia score at H1 H2 H6 H12 H24
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Time frame: FLACC score will be performed from awakenig to 24 hours post surgery
FLACC score mean
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Time frame: FLACC score will be performed from awakenig to 24 hours surgery
individual variations of FLACC score
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Time frame: FLACC score will be performed from awakenig to 24 hours surgery
timing of first injection of nalbuphine
recording date and time of first injection
Time frame: in the first 24 post operative hours
incidence of post operative nausea and vomiting
recording the incidence post operative nausea and vomiting
Time frame: in the first 24 post operative hours
timing of first standing up
recording date and time of first standing up
Time frame: in the first 24 post operative hours
adverse events
adverse event monitoring
Time frame: in the first 24 post operative hours
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