Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy (PAMAL)

August 9, 2023 updated by: University Hospital, Angers

Comparative Retrospective Study on the Different Analgesic Modalities Used for Single-incision Laparoscopic Appendectomy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 15 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients operated on by single-site access for laparoscopic appendectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SILAP patients
This cohort is composed by all pediatric patients operated on for SILAP between January 1st, 2012 and August 31, 2022.
Procedure: SILAP (single incision laparoscopic appendectomy)
Appendectomy performed through transumbilical single access laparoscopy, consisting in the removal of the appendix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the level of pain after SILAP during the 24 first hours after surgery.
Time Frame: 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.
Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the level of pain as measured by the different pain scales routinely used.
Time Frame: 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.
Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the level of pain during the initial post-operative recovery room stay.
Time Frame: 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.
Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the level of pain after the 24 first hours and until hospital release.
Time Frame: 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.
Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.
Time Frame: 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.
Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the types and gravity of peri-operative and post-analgesia complications.
Time Frame: 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.
Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Françoise Schmitt, MD, PhD, University Hospital of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2023

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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