Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 10:50 PM
Study NCT ID:
NCT04969133
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2021-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Study Overview
Official Title:
TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PABLO
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: