Postoperative Pain in Neonates After Abdominal Surgery Using Quadratus Lumborum Block

July 7, 2020 updated by: Pr Isabelle CONSTANT, Hôpital Armand Trousseau

Postoperative Pain in Neonates After Abdominal Surgery Using Ultrasound Guided Quadratus Lumborum Block Performed at the Beginning of the Procedure

Postoperative pain scores and analgesic requirements will be evaluated in neonates after abdominal surgery, with regional quadratus lumborum block performed at the beginning of the procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital Armand Trousseau

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

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates with planned abdominal surgery under general anesthesia, recruited in our neonatology unit.

Description

Inclusion Criteria:

  • abdominal surgery under general anesthesia
  • spontaneously breathing before the procedure

Exclusion Criteria:

  • multiple organ failure
  • mechanical ventilation before the procedure

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
Neonates with abdominal surgery and quadratus lumborum block
0-6 months children with abdominal surgery. After standard induction of general anesthesia, patients will receive 0.5 ml/kg of ropivacaine (2 mg/ml) in a quadratus lumborum block. Ultrasonography will be used to guide the injection. In the postoperative period, pain scores and analgesics consumption will be recorded until the 48th hour post surgery.
Procedure: General anesthesia
Standard general anesthesia
Procedure: Quadratus lumborum block
Guided by ultrasonography, injection of 0.5 ml/kg of ropivacaine (2 mg/ml) between the quadratus lumborum muscle and the internal oblique muscle, before skin incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain score
Time Frame: At the 24th hour after surgery
standard pain scale used in neonatology in our institution: EDIN (Echelle Douleur Inconfort Nourrisson)
At the 24th hour after surgery
morphine consumption
Time Frame: At the 24th hour after surgery
cumulative morphine dose administered to the patient
At the 24th hour after surgery
nalbuphine consumption
Time Frame: At the 24th hour after surgery
cumulative nalbuphine dose administered to the patient
At the 24th hour after surgery
postoperative pain score
Time Frame: At the 24th hour after surgery
standard pain scale used in neonatology in our institution: EVENDOL (EValuation ENfant Douleur)
At the 24th hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: At the 48th hour after surgery
cumulative morphine dose administered to the patient
At the 48th hour after surgery
nalbuphine consumption
Time Frame: At the 48th hour after surgery
cumulative nalbuphine dose administered to the patient
At the 48th hour after surgery

Collaborators and Investigators

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

Sponsor

Hôpital Armand Trousseau

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 (Actual)

June 30, 2017

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARRE DES LOMBES

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

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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