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

Not Applicable

Completed

• Conditions: Appendicitis Acute; Pediatrics; Analgesia
• Interventions: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

• Registration Number: NCT04969133
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-20
• Study Start: 2021-07-30
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block	Levobupivacaine Hydrochloride 2.5 MG/ML	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.
local infiltration of the trocar wounds	Levobupivacaine Hydrochloride 2.5 MG/ML	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.

Primary Outcome Measures

Name	Time	Method
cumulative dose of nalbuphine in the 24 first hours post surgery	24 hours	recording in mg/kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besançon, France