deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT02398123

Transversus Abdominis Plane Versus Caudal Block for Pediatrics

Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.

Sponsor: Mansoura University

Updated 7 times since 2017 Last updated: Sep 14, 2015 Started: Mar 31, 2015 Primary completion: Jun 30, 2015 Completion: Jul 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Lower Abdominal Surgery, this trial is completed. The trial is conducted by Mansoura University and has accumulated 7 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study. Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure. After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 33% oxygen and 66% nitrous oxide; 1ug/kg fentanyl is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing). Anesthesia would be maintained with 2% sevoflurane and nitrous oxide. An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose5% (1:1) solution was infused in a dose of 12 ml/ kg /h. Children were transferred from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten. Patients received rectal paracetamol 15 mg/ kg every 6 hours. Tramadol 1mg/kg is rescue analgesic.

Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.

Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 33% oxygen and 66% nitrous oxide; 1ug/kg fentanyl is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).

Anesthesia would be maintained with 2% sevoflurane and nitrous oxide.

An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose5% (1:1) solution was infused in a dose of 12 ml/ kg /h.

Children were transferred from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

Patients received rectal paracetamol 15 mg/ kg every 6 hours. Tramadol 1mg/kg is rescue analgesic.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2025 — Present [monthly]

    Completed PHASE1

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1

    First recorded

Mar 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mansoura University
Data source: Mansoura University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations