NCT04830280

Brief Summary

We aimed to investigate the effect of posterior quadratus lumborum block on postoperative atelectasis in inguinal hernia surgery in pediatric patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

June 2, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

March 29, 2021

Last Update Submit

June 1, 2021

Conditions

AtelectasisBlockPediatricsQuadratus Lumborum Block

Keywords

postoperative atelectasisultrasoundlung ultrasound scoreposterior QLB

Outcome Measures

Primary Outcomes (1)

  • lung ultrasound score

    atelectasis

    up to 1 hour after surgery

Secondary Outcomes (1)

  • pain scores

    up to 6 hour after surgery

Study Arms (2)

Posterior quadratus lumborum block

ACTIVE COMPARATOR
Procedure: posterior quadratus lumborum block

control group

SHAM COMPARATOR
Procedure: posterior quadratus lumborum block

Interventions

posterior quadratus lumborum blockPROCEDURE

administration local anesthetic solution between the middle layer of the thoracolumbar fascia and QL muscle at the posterior edge of the quadratus lumborum muscle

Posterior quadratus lumborum blockcontrol group

Eligibility Criteria

Age0 Years - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • under 2 years old,
  • ASA I-II risk group
  • Patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method
  • Patients whose informed consent was read and approval was obtained from him and his guardian

You may not qualify if:

  • who do not want to participate in the study,
  • ASA III-IV-V patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary AtelectasisBites and Stings

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 5, 2021

Study Start

March 1, 2021

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

June 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)