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

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Pediatrics; Analgesia; Appendicitis Acute

Treatments: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04969133

2021/571

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

TAP Block

Active Comparator group

Description:

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.

Treatment:

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

local infiltration of the trocar wounds

Active Comparator group

Description:

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.

Treatment:

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML