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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03203031
Other study ID # CARRE DES LOMBES
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 30, 2017
Est. completion date October 1, 2021

Study information

Verified date July 2020
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date October 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- abdominal surgery under general anesthesia

- spontaneously breathing before the procedure

Exclusion Criteria:

- multiple organ failure

- mechanical ventilation before the procedure

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
General anesthesia
Standard general anesthesia
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

Locations

Country Name City State
France Hopital Armand Trousseau Paris

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Armand Trousseau

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain score standard pain scale used in neonatology in our institution: EDIN (Echelle Douleur Inconfort Nourrisson) At the 24th hour after surgery
Primary morphine consumption cumulative morphine dose administered to the patient At the 24th hour after surgery
Primary nalbuphine consumption cumulative nalbuphine dose administered to the patient At the 24th hour after surgery
Primary postoperative pain score standard pain scale used in neonatology in our institution: EVENDOL (EValuation ENfant Douleur) At the 24th hour after surgery
Secondary morphine consumption cumulative morphine dose administered to the patient At the 48th hour after surgery
Secondary nalbuphine consumption cumulative nalbuphine dose administered to the patient At the 48th hour after surgery
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