NCT07281235

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

November 13, 2025

Last Update Submit

December 1, 2025

Conditions

Caudal Block for Postoperative AnalgesiaErector Spinae Plane BlockChildrenLocal Analgesia Via InfiltrationCaudal Epidural AnesthesiaCaudal BlockCaudal Anesthesia

Keywords

Erector Spinae BlockCaudal BlockPediatricsllower abdominal surgery

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (9)

  • Changes to heart rate (beats/minute)

    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

  • The time to first rescue analgesic.

    from 0 to 8 hours after block administration

  • Total postoperative analgesic requirements.

    from 0 to 8 hours after block administration

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

    At 8 hours after block administration

  • Number of patients required rescue analgesic postoperatively.

    From 0 to 8 hours after surgery.

  • +4 more secondary outcomes

Study Arms (2)

Caudal Block Group

ACTIVE COMPARATOR

Patients who received ultrasound guided Caudal Block

Procedure: Caudal Block Anesthesia

Erector Spinae Plane Block Group

ACTIVE COMPARATOR

Patients who received ultrasound guided Erector Spinae Block

Procedure: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Interventions

Ultrasound Guided Bilateral single shot Erector Spinae Plane BlockPROCEDURE

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

Also known as: Ultrasound Guided erector spinae pkane block
Erector Spinae Plane Block Group
Caudal Block AnesthesiaPROCEDURE

Ukltrasound Guided Caudal Epidural Block

Caudal Block Group

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Shatby University Hospital for Children

Alexandria, EL Shatby, Egypt

Location

Related Publications (17)

  • Aksu C, Gurkan Y. Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study of Our Current Experience. Cureus. 2019 Aug 8;11(8):e5348. doi: 10.7759/cureus.5348.

    PMID: 31602352BACKGROUND

  • Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.

    PMID: 7772368BACKGROUND

  • Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009 May;110(5):1061-7. doi: 10.1097/ALN.0b013e31819db079.

    PMID: 19352161BACKGROUND

  • Lucente M, Ragonesi G, Sanguigni M, Sbaraglia F, Vergari A, Lamacchia R, Del Prete D, Rossi M. Erector spinae plane block in children: a narrative review. Korean J Anesthesiol. 2022 Dec;75(6):473-486. doi: 10.4097/kja.22279. Epub 2022 Jul 5.

    PMID: 35790215BACKGROUND

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016BACKGROUND

  • Kollipara N, Kodali VRK, Parameswari A. A randomized double-blinded controlled trial comparing ultrasound-guided versus conventional injection for caudal block in children undergoing infra-umbilical surgeries. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):249-254. doi: 10.4103/joacp.JOACP_361_19. Epub 2021 Jul 15.

    PMID: 34349375BACKGROUND

  • Chen CP, Lew HL, Tang SF. Ultrasound-guided caudal epidural injection technique. Am J Phys Med Rehabil. 2015 Jan;94(1):82-4. doi: 10.1097/PHM.0000000000000047. No abstract available.

    PMID: 24722013BACKGROUND

  • Opfermann P, Kraft F, Obradovic M, Zadrazil M, Schmid W, Marhofer P. Ultrasound-guided caudal blockade and sedation for paediatric surgery: a retrospective cohort study. Anaesthesia. 2022 Jul;77(7):785-794. doi: 10.1111/anae.15738. Epub 2022 Apr 22.

    PMID: 35460068BACKGROUND

  • Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.

    PMID: 28337460BACKGROUND

  • Lamontagne LL, Hepworth JT, Salisbury MH. Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res. 2001 Aug;14(3):119-24. doi: 10.1053/apnr.2001.24410.

    PMID: 11481590BACKGROUND

  • Victoria NC, Murphy AZ. Exposure to Early Life Pain: Long Term Consequences and Contributing Mechanisms. Curr Opin Behav Sci. 2016 Feb;7:61-68. doi: 10.1016/j.cobeha.2015.11.015.

    PMID: 27525299BACKGROUND

  • Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

    PMID: 16882820BACKGROUND

  • Gehdoo Rp. Post operative pain management in paediatric patients. IndianJ Anaesth 2004; 48(5):406-14.

    BACKGROUND

  • Smith HA, Berutti T, Brink E, Strohler B, Fuchs DC, Ely EW, Pandharipande PP. Pediatric critical care perceptions on analgesia, sedation, and delirium. Semin Respir Crit Care Med. 2013 Apr;34(2):244-61. doi: 10.1055/s-0033-1342987. Epub 2013 May 28.

    PMID: 23716315BACKGROUND

  • Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.

    PMID: 30284240BACKGROUND

  • Ingelmo P, Rivera G, Baird R. Pain control after pediatric surgery: learning from the past to perfect the future. Pain Manag. 2016;6(1):9-12. doi: 10.2217/pmt.15.51. Epub 2015 Dec 17. No abstract available.

    PMID: 26677915BACKGROUND

  • Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580.

    PMID: 35793181RESULT

Study Officials

  • Ashraf A Abdelhalim, Doctorate

    Professor of Anesethia and Surgical Intensive Care.

    STUDY CHAIR

  • Ahmed M El Attar, Doctorate

    Professor of Anesethia and Surgical Intensive Care.

    STUDY DIRECTOR

  • Aliaa R Abdel Aziz, Doctorate

    Assistant Professor of Anesethia and Surgical Intensive Care.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 15, 2025

Study Start

May 1, 2024

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

December 15, 2025

Record last verified: 2024-12

Locations

EG(1)