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Completed

NCT Number: NCT06530147

Transversalis Fascia Plane Block vs Transversus Abdominis Plane Block In Pediatric Surgeries

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

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Key information

Conditions

Postoperative Analgesia

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasibe Irban

Kocaeli, 41000, Turkey (Türkiye)

About this study

After being informed about the study and potential risks, written consent was obtained from all patients. In order to effectively manage postoperative analgesia in patients planned for lower abdominal surgery (inguinal hernia and undescended testicles), patients will begin to be observed after routine anesthesia and block techniques applied to the patients. After these procedures, the block is applied to the patient using the appropriate method, under aseptic conditions and under ultrasound guidance. Intraoperative hemodynamic changes of the patients, intraoperative opioid consumption and bispectral index monitoring values of the patients will be kept throughout the peroperative period. Postoperative follow-ups will be made at 0nd, 1st, 2nd, 4th, 6th, 12th, and 24th hours to evaluate the initial analgesic consumption, need for analgesics types, pain levels, and parental satisfaction. In this way, it is aimed to compare the Transversalis Fascia Plan Block and Transversus Abdominis Plan Block as an effective analgesic application in lower abdominal surgery in children and to show the analgesic method that can be used effectively in postoperative pain management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologist Classification (ASA) I-II patients
  • 1-7 aged patients
  • patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)

Exclusion criteria

  • 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.

Treatment and study plan

transversalis fascia plane block

Other

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

Transversus abdominis plane block

Other

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

Primary outcomes

  1. Pain scores

    Time frame: at the 6th postoperative hou

    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.

Secondary outcomes

  1. Pain scores

    Time frame: During postoperative 24 hours

    Secondary objectives will include comparison of patient FLACC (Face, Legs, Activity, Cry, Consolability) pain scores in 24-hour observations of patients. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.

  2. Need for analgesic

    Time frame: During postoperative 24 hours

    It should be recorded whether there is a need for analgesics.

  3. Nause and vomiting

    Time frame: During postoperative 24 hours

    The presence or absence of nausea and vomiting symptoms will be recorded.

  4. Parents satisfaction

    Time frame: During postoperative 24 hours

    Parental satisfaction was assessed on a scale ranging from 1 to 5 points parents satisfaction with the applied analgesia methods was evaluated on a scale from 1, indicating the lowest satisfaction, to 5, indicating the highest satisfaction.

  5. Time elapsed until the first analgesic requirement

    Time frame: During postoperative 24 hours

    What type of analgesic is needed. The time elapsed until the first analgesic requirement was recorded.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Comparison Of The Effectiveness Of Transversalis Fascia Plane Block And Transversus Abdominis Plane Block For Postoperative Analgesia After Pediatric Lower Abdominal Surgeries

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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