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

Primary Purpose

Appendicitis Acute, Pediatrics, Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Levobupivacaine Hydrochloride 2.5 MG/ML
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Appendicitis Acute focused on measuring Appendicectomy, Laparoscopy, infiltration, TAP block

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • CHU BesanconRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP Block

local infiltration of the trocar wounds

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

cumulative dose of nalbuphine H0-H12 post surgery
recording in mg/kg
cumulative dose of nalbuphine H13-H24 post surgery
recording in mg/kg
FLACC analgesia score at H1 H2 H6 H12 H24
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
FLACC score mean
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
individual variations of FLACC score
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
timing of first injection of nalbuphine
recording date and time of first injection
incidence of post operative nausea and vomiting
recording the incidence post operative nausea and vomiting
timing of first standing up
recording date and time of first standing up
adverse events
adverse event monitoring

Full Information

First Posted
June 18, 2021
Last Updated
March 29, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04969133
Brief Title
TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children
Acronym
PABLO
Official Title
TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute, Pediatrics, Analgesia
Keywords
Appendicectomy, Laparoscopy, infiltration, TAP block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP Block
Arm Type
Active Comparator
Arm 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.
Arm Title
local infiltration of the trocar wounds
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine Hydrochloride 2.5 MG/ML
Intervention Description
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 Outcome Measure Information:
Title
cumulative dose of nalbuphine in the 24 first hours post surgery
Description
recording in mg/kg
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
cumulative dose of nalbuphine H0-H12 post surgery
Description
recording in mg/kg
Time Frame
from beginning to 12th hour
Title
cumulative dose of nalbuphine H13-H24 post surgery
Description
recording in mg/kg
Time Frame
From 13th hour to 24th hour
Title
FLACC analgesia score at H1 H2 H6 H12 H24
Description
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Time Frame
FLACC score will be performed from awakenig to 24 hours post surgery
Title
FLACC score mean
Description
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Time Frame
FLACC score will be performed from awakenig to 24 hours surgery
Title
individual variations of FLACC score
Description
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Time Frame
FLACC score will be performed from awakenig to 24 hours surgery
Title
timing of first injection of nalbuphine
Description
recording date and time of first injection
Time Frame
in the first 24 post operative hours
Title
incidence of post operative nausea and vomiting
Description
recording the incidence post operative nausea and vomiting
Time Frame
in the first 24 post operative hours
Title
timing of first standing up
Description
recording date and time of first standing up
Time Frame
in the first 24 post operative hours
Title
adverse events
Description
adverse event monitoring
Time Frame
in the first 24 post operative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie JURINE, Doctor
Phone
0033381669403
Email
ajurine@chu-besancon.fr
Facility Information:
Facility Name
CHU Besancon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie JURINE, Doctor
Phone
+33381669403
Email
ajurine@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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