NCT03463382

Brief Summary

Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

February 28, 2018

Last Update Submit

November 12, 2018

Conditions

Postoperative Pain

Keywords

Pediatric SurgeryPostoperative PainErector spinae plane blockquadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    Postoperative first 6hours

Secondary Outcomes (2)

  • Time to first analgesic drug

    first 48 hour

  • Need for analgesic

    24 hour

Study Arms (2)

ESP Group

ACTIVE COMPARATOR

Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

Procedure: Erector Spinae Plane BlockDrug: Bupivacaine (Block Drug)

QLB Group

ACTIVE COMPARATOR

Quadratus Lumborum Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

Procedure: Quadratus Lumborum BlockDrug: Bupivacaine (Block Drug)

Interventions

Erector Spinae Plane BlockPROCEDURE

Erector Spinae Plane block will be administered under general anesthesia before the surgery

ESP Group
Quadratus Lumborum BlockPROCEDURE

Quadratus Lumborum Block will be administered under general anesthesia before the surgery

QLB Group
Bupivacaine (Block Drug)DRUG

0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances

ESP GroupQLB Group

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • ASA I-II
  • Undergoing elective low abdominal surgery

You may not qualify if:

  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • ASA III-IV
  • Patients with neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Location

Related Publications (1)

  • Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.

    PMID: 30851499DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 13, 2018

Study Start

March 12, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)