NCT03294291

Brief Summary

The purpose of this research study is to find the best way to decrease pain in children whom have had low abdominal surgery. Investigators will perform two technique;Caudal block or Quadratus lumborum block .The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method. The results of this study will help learn how to best control pain in children having surgery low abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2017

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

September 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

September 22, 2017

Last Update Submit

November 15, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Use of analgesic consumption

    paracetamol

    24 hour

Secondary Outcomes (3)

  • Flacc score( face, legs, activity, cry, consolability)

    1,2,4,6,12,24 hou

  • Parent satisfaction scores

    24 hour

  • Time to first use of analgesic

    24 hour

Study Arms (2)

Quadratus Lumborum block group

ACTIVE COMPARATOR

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.

Procedure: Quadratus lumborum block

Caudal block

ACTIVE COMPARATOR

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.

Procedure: Caudal block

Interventions

Quadratus lumborum blockPROCEDURE

Postoperative pain procedure

Quadratus Lumborum block group
Caudal blockPROCEDURE

Postoperative pain procedure

Caudal block

Eligibility Criteria

Age1 Year - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-9
  • ASA physical status I-II
  • Undergoing unilateral low abdominal surgery

You may not qualify if:

  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  • Parent refusal
  • History of allergic reactions to local anesthetics
  • Rash or infection at the injection site
  • Anatomical abnormality
  • Bleeding diatheses
  • Coagulopathy,
  • History of diseases
  • renal
  • hepatic
  • cardiac
  • upper or lower airway
  • neurological

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KahramanmarasSIU

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (2)

  • Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.

    PMID: 28759502RESULT

  • Oksuz G, Arslan M, Urfalioglu A, Guler AG, Teksen S, Bilal B, Oksuz H. Comparison of quadratus lumborum block and caudal block for postoperative analgesia in pediatric patients undergoing inguinal hernia repair and orchiopexy surgeries: a randomized controlled trial. Reg Anesth Pain Med. 2020 Mar;45(3):187-191. doi: 10.1136/rapm-2019-101027. Epub 2020 Jan 5.

    PMID: 31907294DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gözen Öksüz, M.D.

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All Children will be randomly assigned to one of 2 groups of 25 patients each using a computer-generated number table.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 27, 2017

Study Start

December 1, 2017

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)