NCT03258736

Brief Summary

The caudal block is the most common technique for inguinal surgery. Increased use of ultrasound in regional analgesia techniques has been improved the practise of the peripheral nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative methods to the central blocks. The aim of this study is to compare analgesic efficiency of caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for bilateral inguinal hernia in pediatric patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable surgery

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

April 4, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

November 17, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

August 20, 2017

Last Update Submit

November 14, 2017

Conditions

Surgery

Keywords

pediatric, inguinal hernia, caudal, ilioinguinal/ilioihypogastric

Outcome Measures

Primary Outcomes (1)

  • Analgesic requirements

    FLACC score

    up to 24 hours

Secondary Outcomes (1)

  • Postoperative complications

    up to 24 hours

Study Arms (2)

Caudal block

OTHER

Caudal block Marcaine

Procedure: inguinal hernia surgery

ilionguinal/iliohypogastric block

OTHER

ilionguinal/iliohypogastric block Marcaine

Procedure: inguinal hernia surgery

Interventions

inguinal hernia surgeryPROCEDURE

repair of inguinal hernia

Caudal blockilionguinal/iliohypogastric block

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty

Istanbul, Cerrahpasa, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof

Study Record Dates

First Submitted

August 20, 2017

First Posted

August 23, 2017

Study Start

April 4, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

November 17, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Availabe from the authors

Locations

TU(1)