Postoperative PainNCT03203031
Postoperative Pain in Neonates After Abdominal Surgery Using Quadratus Lumborum Block
An observational study of Postoperative Pain, run by Hôpital Armand Trousseau at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- General anesthesia and Quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2017to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with planned abdominal surgery under general anesthesia, recruited in our neonatology unit.
Who may be able to join
- abdominal surgery under general anesthesia
- spontaneously breathing before the procedure
Who cannot join
- multiple organ failure
- mechanical ventilation before the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postoperative Pain
- Being tested
- General anesthesia, Quadratus lumborum block
- Keywords
- pain, neonate, regional anesthesia, postoperative
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Standard general anesthesia
Quadratus lumborum blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: General anesthesia; Procedure: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
standard pain scale used in neonatology in our institution: EDIN (Echelle Douleur Inconfort Nourrisson)
Measured: At the 24th hour after surgery
morphine consumption
cumulative morphine dose administered to the patient
Measured: At the 24th hour after surgery
nalbuphine consumption
cumulative nalbuphine dose administered to the patient
Measured: At the 24th hour after surgery
postoperative pain score
standard pain scale used in neonatology in our institution: EVENDOL (EValuation ENfant Douleur)
Measured: At the 24th hour after surgery
Secondary outcomes (2)
morphine consumption
cumulative morphine dose administered to the patient
Measured: At the 48th hour after surgery
nalbuphine consumption
cumulative nalbuphine dose administered to the patient
Measured: At the 48th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start30 Jun 2017
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Isabelle Constant, MD-PHD, Study director, Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203031
- Sponsor's protocol ID
- CARRE DES LOMBES
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2017
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain in Neonates After Abdominal Surgery Using Ultrasound Guided Quadratus Lumborum Block Performed at the Beginning of the Procedure
- ClinicalTrials.gov ID
- NCT03203031
- Acronym / sponsor ID
- CARRE DES LOMBES
- Conditions
- Postoperative Pain
- Keywords
- pain, neonate, regional anesthesia, postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with abdominal surgery and quadratus lumborum block | – | Procedure: General anesthesia, Procedure: Quadratus lumborum block0-6 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with planned abdominal surgery under general anesthesia, recruited in our neonatology unit.
Key inclusion criteria (2 listed)
- abdominal surgery under general anesthesia
- spontaneously breathing before the procedure
Key exclusion criteria (2 listed)
- multiple organ failure
- mechanical ventilation before the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaStandard general anesthesia | Procedure or surgery | Neonates with abdominal surgery and quadratus lumborum block |
| Quadratus lumborum blockGuided 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 | Procedure or surgery | Neonates with abdominal surgery and quadratus lumborum block |
Primary outcome
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)
morphine consumption
Time frame: At the 24th hour after surgery
cumulative morphine dose administered to the patient
nalbuphine consumption
Time frame: At the 24th hour after surgery
cumulative nalbuphine dose administered to the patient
postoperative pain score
Time frame: At the 24th hour after surgery
standard pain scale used in neonatology in our institution: EVENDOL (EValuation ENfant Douleur)
2 secondary outcomes
morphine consumption
Time frame: At the 48th hour after surgery
nalbuphine consumption
Time frame: At the 48th hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Constant, MD-PHD study director
Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Hôpital Armand Trousseau at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: At the 24th hour after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.