NCT06530147

Brief Summary

In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

July 5, 2024

Last Update Submit

August 6, 2024

Conditions

Postoperative Analgesia

Keywords

Regional anaesthesiaTransversus Abdominis Plane BlockTransversalis Fascia Plane BlockPediatric Lower Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Our primary aim to compare the effect of both blocks groups on the FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at the 6th postoperative hour. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.

    at the 6th postoperative hou

Secondary Outcomes (5)

  • Pain scores

    During postoperative 24 hours

  • Need for analgesic

    During postoperative 24 hours

  • Nause and vomiting

    During postoperative 24 hours

  • Parents satisfaction

    During postoperative 24 hours

  • Time elapsed until the first analgesic requirement

    During postoperative 24 hours

Study Arms (2)

Transversalis Fascia Plane Block

One-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.

Other: Transversalis Fascia Plane Block

Transversus Abdominis Plane Block

One-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.

Other: Transversus Abdominis Plane Block

Interventions

Transversalis Fascia Plane BlockOTHER

One-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.

Transversalis Fascia Plane Block
Transversus Abdominis Plane BlockOTHER

One-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.

Transversus Abdominis Plane Block

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients aged between 1 and 7 years who will undergo abdominal surgery will be included in the study.

You may qualify if:

  • American Society of Anesthesiologist Classification (ASA) I-II patients
  • aged patients
  • patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)

You may not qualify if:

  • Use of anticoagulants
  • Allergy of medications to be used
  • Presence of infection the area where the block will be applied
  • American Society of Anesthesiologist Classification (ASA) III-IV patients
  • The study will not include any vulnerable population, such as those in restraints, those in intensive care and those who are unconscious, and those who cannot give personal consent or impressionable subjects.
  • Patients who do not agree to participate in the research, parents/legal guardians
  • Patients who were operated on with a different incision than planned for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasibe Irban

Kocaeli, 41000, Turkey (Türkiye)

Location

Related Publications (1)

  • Irban H, Aksu C. Comparison of the effectiveness of transversalis fascia plane block and transversus abdominis plane block for postoperative analgesia in pediatric lower abdominal surgeries: prospective, single blinded study. BMC Anesthesiol. 2025 Apr 5;25(1):154. doi: 10.1186/s12871-025-03023-z.

    PMID: 40188032DERIVED

Study Officials

  • Can Aksu

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 31, 2024

Study Start

June 15, 2022

Primary Completion

July 29, 2024

Study Completion

August 6, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

TU(1)