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

Analgesia Clinical Trial

— PABLO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969133
• Other study ID #: 2021/571
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: May 25, 2024

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Amélie JURINE, Doctor
• Phone: 0033381669403
• Email: ajurine[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 25, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Appendicitis
• Appendicitis Acute
• Pain, Postoperative
• Pediatrics

Intervention

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

Locations

Country	Name	City	State
France	CHU Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative dose of nalbuphine in the 24 first hours post surgery	recording in mg/kg	24 hours
Secondary	cumulative dose of nalbuphine H0-H12 post surgery	recording in mg/kg	from beginning to 12th hour
Secondary	cumulative dose of nalbuphine H13-H24 post surgery	recording in mg/kg	From 13th hour to 24th hour
Secondary	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
Secondary	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
Secondary	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
Secondary	timing of first injection of nalbuphine	recording date and time of first injection	in the first 24 post operative hours
Secondary	incidence of post operative nausea and vomiting	recording the incidence post operative nausea and vomiting	in the first 24 post operative hours
Secondary	timing of first standing up	recording date and time of first standing up	in the first 24 post operative hours
Secondary	adverse events	adverse event monitoring	in the first 24 post operative hours