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NCT Number: NCT07281235

Perioperative Analgesia Using Ultrasound Guided Erector Spinae Block vs Ultrasound Guided Caudal Block for Pain Control in Children Aged 2-7 Years Undergoing Lower Abdominal Surgery

The goal of this prospective study is to is to evaluate the perioperative pain management of Erector Spinae Block versus Caudal Block using the Face, Legs, Activity, Cry, Conceal ability (FLACC) Pain Scale inn children aged 2 to 7 years old. The main question it aims to answer is:

Which block is more efficient in the perioperative period?

Participants will be evaluated intraoperative and postoperative for hemodynamic changes and their pain will evaluated according to the FLACC score.

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Key information

Conditions

Local Analgesia Via Infiltration Caudal Anesthesia Caudal Block Caudal Block for Postoperative Analgesia Caudal Epidural Anesthesia Children Erector Spinae Plane Block

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Shatby University Hospital for Children

Alexandria, EL Shatby, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 2-7 years old.
  • ASA I-II.
  • Elective surgery under general anaesthesia.
  • Lower abdominal surgery.

Exclusion criteria

  • Parent/caregiver refusal.
  • Allergy to one of the study medications.
  • Renal or cardiac disease.
  • Infection or redness at the site of injection.
  • Clinically significant coagulopathy.
  • Spinal anomalies.
  • Altered mental status.
  • Developmental delay.
  • Additional surgery at different surgical sites.
  • Block failure.

Treatment and study plan

Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Procedure

Ultrasound Guided Erector Spinae Plane block given bilaterally at level of L1.

Other names: Ultrasound Guided erector spinae pkane block

Caudal Block Anesthesia

Procedure

Ukltrasound Guided Caudal Epidural Block

Primary outcomes

  1. Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.

    Time frame: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.

    Evaluate postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.

    A score of 0 = no pain, 10 = severe pain. A score ≥4 requires rescue analgesia.

Secondary outcomes

  1. Changes to heart rate (beats/minute)

    Time frame: T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery

    Changes to heart rate (beats/minute) recorded before surgery, during surgery and immediately after surgery

  2. The time to first rescue analgesic.

    Time frame: from 0 to 8 hours after block administration

    Time from block administration to the patient's first requirement for rescue analgesia.

  3. Total postoperative analgesic requirements.

    Time frame: from 0 to 8 hours after block administration

    Amount and frequency of analgesia patient requested

  4. Parent satisfaction with a 5-point Likert scale questionnaire.

    Time frame: At 8 hours after block administration

    Parent or caregiver satisfaction about block efficiency on a scale of 1 to 5.

  5. Number of patients required rescue analgesic postoperatively.

    Time frame: From 0 to 8 hours after surgery.

    Number of patiebts of asked for rescue analgesia is recorded.

  6. Time to Modified Aldrete score ≥9.

    Time frame: from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes)

    Postoperative recovery was assessed using the Modified Aldrete Scoring System, which evaluates five physiological criteria: activity, respiration, circulation, consciousness, and oxygen saturation

  7. Incidence of any adverse effects.

    Time frame: from end of surgery (0 hours) to 8 hours postoperatively

    Any side effects reported by the patient related to analgesia.

  8. Changes to mean arterial pressure (MAP)

    Time frame: T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery

    changes to mean arterial pressure (MAP) (mmHg) before surgery, during surgery and immediately after surgey

  9. Changes to oxygen saturation

    Time frame: T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery

    Changes to oxygen saturation before surgery, during surgery and immediately after surgery.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Perioperative Analgesia With Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Caudal Block in Children

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

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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