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

TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic 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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Pediatrics; Appendicitis Acute
• Intervention / Treatment: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amélie JURINE, Doctor; Phone Number: 0033381669403; Email: ajurine@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU Besançon
    • Contact: Amélie JURINE, Doctor; Phone Number: +33381669403; Email: ajurine@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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
Active Comparator: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative dose of nalbuphine in the 24 first hours post surgery	recording in mg/kg	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative dose of nalbuphine H0-H12 post surgery	recording in mg/kg	from beginning to 12th hour
cumulative dose of nalbuphine H13-H24 post surgery	recording in mg/kg	From 13th hour to 24th hour
FLACC analgesia score at H1 H2 H6 H12 H24	Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10	FLACC score will be performed from awakenig to 24 hours post surgery
FLACC score mean	Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10	FLACC score will be performed from awakenig to 24 hours surgery
individual variations of FLACC score	Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10	FLACC score will be performed from awakenig to 24 hours surgery
timing of first injection of nalbuphine	recording date and time of first injection	in the first 24 post operative hours
incidence of post operative nausea and vomiting	recording the incidence post operative nausea and vomiting	in the first 24 post operative hours
timing of first standing up	recording date and time of first standing up	in the first 24 post operative hours
adverse events	adverse event monitoring	in the first 24 post operative hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Anticipated): December 25, 2023
• Study Completion (Anticipated): May 25, 2024

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopy; TAP block; infiltration; Appendicectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Pain, Postoperative; Appendicitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: 2021/571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No