Postoperative Pain in Neonates After Abdominal Surgery Using Quadratus Lumborum Block

NCT03203031 | Unknown

• 1 other identifier: CARRE DES LOMBES
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

pain; neonate; regional anesthesia; postoperative

Outcome Measures

Primary Outcomes (4)

• postoperative pain score

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

  At the 24th hour after surgery

• morphine consumption

  cumulative morphine dose administered to the patient

  At the 24th hour after surgery

• nalbuphine consumption

  cumulative nalbuphine dose administered to the patient

  At the 24th hour after surgery

• postoperative pain score

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

  At the 24th hour after surgery

Secondary Outcomes (2)

• morphine consumption

  At the 48th hour after surgery

• nalbuphine consumption

  At the 48th hour after surgery

Study Arms (1)

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

General anesthesia PROCEDURE

Standard general anesthesia

Neonates with abdominal surgery and quadratus lumborum block

Quadratus lumborum block PROCEDURE

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

Neonates with abdominal surgery and quadratus lumborum block

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• multiple organ failure
• mechanical ventilation before the procedure

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead

Study Sites (1)

Hopital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Isabelle Constant, MD-PHD

  Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 29, 2017
• Study Start: June 30, 2017
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

FR (1)