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

NCT ID: NCT07281235

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Caudal Block Group

Patients who received ultrasound guided Caudal Block

Group Type ACTIVE_COMPARATOR

Caudal Block Anesthesia

Intervention Type PROCEDURE

Ukltrasound Guided Caudal Epidural Block

Erector Spinae Plane Block Group

Patients who received ultrasound guided Erector Spinae Block

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Intervention Type PROCEDURE

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

Interventions

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Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

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

Intervention Type PROCEDURE

Caudal Block Anesthesia

Ukltrasound Guided Caudal Epidural Block

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound Guided erector spinae pkane block

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashraf A Abdelhalim, Doctorate

Role: STUDY_CHAIR

Professor of Anesethia and Surgical Intensive Care.

Ahmed M El Attar, Doctorate

Role: STUDY_DIRECTOR

Professor of Anesethia and Surgical Intensive Care.

Aliaa R Abdel Aziz, Doctorate

Role: STUDY_DIRECTOR

Assistant Professor of Anesethia and Surgical Intensive Care.

Locations

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El Shatby University Hospital for Children

Alexandria, EL Shatby, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 35460068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28337460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11481590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27525299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16882820 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 23716315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30284240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26677915 (View on PubMed)

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.

Reference Type RESULT
PMID: 35793181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31602352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7772368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19352161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35790215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34349375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24722013 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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9250511

Identifier Type: -

Identifier Source: org_study_id

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