NCT04969133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

April 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

June 18, 2021

Last Update Submit

April 18, 2025

Conditions

Appendicitis AcutePediatricsAnalgesia

Keywords

AppendicectomyLaparoscopyinfiltrationTAP block

Outcome Measures

Primary Outcomes (1)

  • cumulative dose of nalbuphine in the 24 first hours post surgery

    recording in mg/kg

    24 hours

Secondary Outcomes (9)

  • cumulative dose of nalbuphine H0-H12 post surgery

    from beginning to 12th hour

  • cumulative dose of nalbuphine H13-H24 post surgery

    From 13th hour to 24th hour

  • FLACC analgesia score at H1 H2 H6 H12 H24

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

  • FLACC score mean

    FLACC score will be performed from awakenig to 24 hours surgery

  • individual variations of FLACC score

    FLACC score will be performed from awakenig to 24 hours surgery

  • +4 more secondary outcomes

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

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

local infiltration of the trocar wounds

ACTIVE COMPARATOR

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

Interventions

Levobupivacaine Hydrochloride 2.5 MG/MLDRUG

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

TAP Blocklocal infiltration of the trocar wounds

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

AppendicitisAgnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 20, 2021

Study Start

July 30, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

April 23, 2025

Record last verified: 2025-01

Locations

FR(1)