NCT04209478

Brief Summary

In the pediatric age group, postoperative pain is very important for the children to have a comfortable and problem-free postoperative period. In the present study, it was aimed to compare the postoperative analgesic efficacy of Transversus abdominis plane (TAP) Block, and quadratus lumborum block (QLB) Type 1 on the pediatric patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 20, 2019

Last Update Submit

January 10, 2020

Conditions

Keywords

quadratus lumborum blockpediatric anesthesiatransverse abdominal block

Outcome Measures

Primary Outcomes (1)

  • the analgesic use of the groups in 24 hours

    the number of analgesic requirements

    how many times in 24 hours

Study Arms (2)

TAP Block

EXPERIMENTAL

Cases were assessed transversus abdominis plane block for postoperative analgesia

Drug: Tramadol hydrochloride

QL Block

EXPERIMENTAL

Cases were assessed quadratus lumborum block for postoperative analgesia

Drug: Tramadol hydrochloride

Interventions

The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration

Also known as: morphine hydrochloride
QL BlockTAP Block

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with American Society of Anesthesiologist I-II level.

You may not qualify if:

  • Cases with American Society of Anesthesiologist III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Döndü Genç Moralar

Istanbul, 34000, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

May 1, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations