Transversalis Fascia Plane Block in Pediatric Patients

NCT ID: NCT06391528

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Pain, Postoperative Regional Anesthesia Parental Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Group FTB

Group Type ACTIVE_COMPARATOR

Transversalis Fascia Plane Block

Intervention Type 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.

Interventions

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Transversalis Fascia Plane Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zonguldak Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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Çağdaş Baytar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zonguldak Bülent Ecevit University medicine faculty

Zonguldak, Kozlu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024/06-19

Identifier Type: -

Identifier Source: org_study_id

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