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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2024-01-31

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.

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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.

Conditions

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Appendicitis Acute Pediatrics Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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TAP Block

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.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type DRUG

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

local infiltration of the trocar wounds

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.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type DRUG

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

Interventions

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Levobupivacaine Hydrochloride 2.5 MG/ML

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

Intervention Type DRUG

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No