Transversalis Fascia Plane Block in Pediatric Patients | NCT06391528

Studies
Transversalis Fascia Plane Block in Pediatric Patients

NCT06391528

Sponsor

Zonguldak Bulent Ecevit University

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Pain, Postoperative
Regional Anesthesia
Parental Satisfaction

Interventions

Transversalis Fascia Plane Block

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Apr 26, 2024

First Submission Date that Met QC Criteria

Apr 26, 2024

First Posted Date

Apr 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2024

Last Update Posted Date

Apr 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Çağdaş Baytar, Principal Investigator, Zonguldak Bulent Ecevit UniversityPrincipal Investigator

Lead Sponsor

Zonguldak Bulent Ecevit UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Control	No Intervention
Group FTB	Active Comparator		Procedure: Transversalis Fascia Plane Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transversalis Fascia Plane Block	Procedure	application of local anesthetic between the transversus abdominis muscle and the transversalis fascia surrounding it from the inside, at the level of the posterior axillary line.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pain scores	Patients will be evaluated at regular intervals after surgery and their pain will be measured using a FLACC scores.	up to 24 hour after surgery

Secondary Outcomes

Measure	Description	Time Frame
parental satisfaction	asking parents about their satisfaction	during the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-9 years old
ASA I-II risk group
Patients whose consent was obtained from their parents with an informed consent form
Patients who will undergo Inguinal Hernia or Undescended Testi

Exclusion Criteria:

ASA >2
History of allergy to local anesthetics
Known coagulation disorders
Infection near the entry site
Body mass index >30
Those whose parents refused to participate in the study
Those contraindicated for regional anesthesia
Those with neurological or neuromuscular disease
Patients with psychiatric problems
Patients with a history of opioid use
Chronic analgesic use
Operation duration exceeding 2 hours

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University medicine faculty		Zonguldak	Kozlu	67600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided