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Status unknownNCT03203031Updated Jul 8, 2020

Postoperative Pain in Neonates After Abdominal Surgery Using Quadratus Lumborum Block

An observational study in Postoperative Pain, sponsored by Hôpital Armand Trousseau. Status unknown at 1 site in France. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Hôpital Armand Trousseau · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
Up to 6 Months
Sex
All
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Study 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.

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Conditions studied

  • Postoperative Pain

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Keywords

  • pain
  • neonate
  • regional anesthesia
  • postoperative
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 10 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Hôpital Armand Trousseau is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • multiple organ failure
  • mechanical ventilation before the procedure
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Procedure: Quadratus lumborum block

Interventions

  • ProcedureGeneral anesthesia

    Standard general anesthesia

  • ProcedureQuadratus 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

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What researchers measure

Primary outcomes

  1. postoperative pain score

    standard pain scale used in neonatology in our institution: EDIN (Echelle Douleur Inconfort Nourrisson)

    Time frame: At the 24th hour after surgery

  2. morphine consumption

    cumulative morphine dose administered to the patient

    Time frame: At the 24th hour after surgery

  3. nalbuphine consumption

    cumulative nalbuphine dose administered to the patient

    Time frame: At the 24th hour after surgery

  4. postoperative pain score

    standard pain scale used in neonatology in our institution: EVENDOL (EValuation ENfant Douleur)

    Time frame: At the 24th hour after surgery

Secondary outcomes

  1. morphine consumption

    cumulative morphine dose administered to the patient

    Time frame: At the 48th hour after surgery

  2. nalbuphine consumption

    cumulative nalbuphine dose administered to the patient

    Time frame: At the 48th hour after surgery

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Study locations

1 site
  • Hopital Armand Trousseau
    Paris, 75012, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03203031
Lead sponsor
Hôpital Armand Trousseau
Responsible party
Pr Isabelle CONSTANT (Professor, Hôpital Armand Trousseau) — Principal investigator
First posted
Jun 29, 2017
Start date
Jun 30, 2017
Primary completion
Jul 1, 2021 (estimated)
Completion
Oct 1, 2021 (estimated)
Last update
Jul 8, 2020

Study contacts

Isabelle Constant, MD-PHD
study director · Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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