TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children

Conditions
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Appendicitis Acute, Pediatrics, Analgesia

Intervention / Treatment
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* Drug: Levobupivacaine Hydrochloride 2.5 MG/ML


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block<br>Transverse abdominal block is realisated at the beginning of the surgery with ultrasound guided technique with levobupivacaine 2.5mg/mL, 0.3mL/kg each side. The patient receives usual analgesia protocol. | Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* 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<br>|
| Active Comparator: local infiltration of the trocar wounds<br>local infiltration of the trocar wounds is realisated at the end of the surgery by the surgeon with levobupivacaine 2.5mg/mL 0.6mL/kg distributed in each trocar opening. The patient receives usual analgesia protocol. | Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative dose of nalbuphine in the 24 first hours post surgery | recording in mg/kg | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative dose of nalbuphine H0-H12 post surgery | recording in mg/kg | from beginning to 12th hour | 
| cumulative dose of nalbuphine H13-H24 post surgery | recording in mg/kg | 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 | 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 | 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 | FLACC score will be performed from awakenig to 24 hours surgery | 
| timing of first injection of nalbuphine | recording date and time of first injection | in the first 24 post operative hours | 
| incidence of post operative nausea and vomiting | recording the incidence post operative nausea and vomiting | in the first 24 post operative hours | 
| timing of first standing up | recording date and time of first standing up | in the first 24 post operative hours | 
| adverse events | adverse event monitoring | in the first 24 post operative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendicectomy, Laparoscopy, infiltration, TAP block