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Completed

NCT Number: NCT04969133

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

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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Key information

Conditions

Appendicitis Acute Agnosia Analgesia Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatrics Perceptual Disorders Signs and Symptoms

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Besancon

Besançon, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine Hydrochloride 2.5 MG/ML

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

Primary outcomes

  1. cumulative dose of nalbuphine in the 24 first hours post surgery

    Time frame: 24 hours

    recording in mg/kg

Secondary outcomes

  1. cumulative dose of nalbuphine H0-H12 post surgery

    Time frame: from beginning to 12th hour

    recording in mg/kg

  2. cumulative dose of nalbuphine H13-H24 post surgery

    Time frame: From 13th hour to 24th hour

    recording in mg/kg

  3. FLACC analgesia score at H1 H2 H6 H12 H24

    Time frame: FLACC score will be performed from awakenig to 24 hours post surgery

    Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10

  4. FLACC score mean

    Time frame: FLACC score will be performed from awakenig to 24 hours surgery

    Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10

  5. individual variations of FLACC score

    Time frame: FLACC score will be performed from awakenig to 24 hours surgery

    Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10

  6. timing of first injection of nalbuphine

    Time frame: in the first 24 post operative hours

    recording date and time of first injection

  7. incidence of post operative nausea and vomiting

    Time frame: in the first 24 post operative hours

    recording the incidence post operative nausea and vomiting

  8. timing of first standing up

    Time frame: in the first 24 post operative hours

    recording date and time of first standing up

  9. adverse events

    Time frame: in the first 24 post operative hours

    adverse event monitoring

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: PABLO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2021
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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