Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy

Not yet recruiting

• Conditions: Appendicitis
• Interventions: Procedure: SILAP (single incision laparoscopic appendectomy)

• Registration Number: NCT05773521
• Lead Sponsor: University Hospital, Angers

Brief Summary

Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.

Detailed Description

The aim of this retrospective study is to describe the different types of perioperative analgesia routinely used and to compare them to determine the more efficient one for early postoperative pain relief.

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Study Start: 2023-08-31
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• All patients operated on for appendectomy by SILAP, aged 15 years and under in our pediatric surgical center.

Exclusion Criteria

• Patients aged 16 years or more.
• Patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...)
• Patients with contraindications for the use of IV analgesics.
• patients operated on for appendectomy through 3-ports laparoscopy or open surgery.
• Opposition of the patients and their representative to the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SILAP patients	SILAP (single incision laparoscopic appendectomy)	This cohort is composed by all pediatric patients operated on for SILAP between January 1st, 2012 and August 31, 2022.

Primary Outcome Measures

Name	Time	Method
To assess the level of pain after SILAP during the 24 first hours after surgery.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age	Objectified by the quantity of level 2-3 (in morphin equivalent) analgesic used up to 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
To assess the level of pain during the initial post-operative recovery room stay.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age	Objectified by the higher level of pain quoted during the first 24 hours after surgery and by the amount of level 2-3 analgesic used.
To assess the level of pain after the 24 first hours and until hospital release.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age	Objectified by the higher level of pain quoted from 24 hours post-operative to hospital discharge, and by the amount of level 2-3 analgesic used.
To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age	Objectified by the amount of level 2-3 analgesics used in post-operative recovery room and during hospital stay.
To assess the types and gravity of peri-operative and post-analgesia complications.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age	Objectified by the description of complications encountered and classified with the Clavien and Dindo gravity scale for surgical complications.
To assess the level of pain as measured by the different pain scales routinely used.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age	Objectified by the higher level of pain quoted during the first 24 hours after surgery.

Trial Locations

Locations (1)

Angers University Hospital; 🇫🇷 Angers, France