Transversalis Fascia Plane Block in Pediatric Patients

NCT06391528 | Active Not Recruiting

• 1 other identifier: 2024/06-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Regional Anesthesia; Parental Satisfaction

Keywords

postoperative pain; pain scores

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• parental satisfaction

  during the procedure

Study Arms (2)

Group Control

NO INTERVENTION

Group FTB

ACTIVE COMPARATOR

Procedure: Transversalis Fascia Plane Block

Interventions

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.

Group FTB

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University medicine faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)