Comparison of Two Different Analgesic Regional Block Techniques in Pediatric Patients Undergoing a Hernia Repair

NCT05896072 | Unknown

• 1 other identifier: AIBU-TF-AR-II-003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 7

Brief Summary

Lower abdominal operations; especially inguinal hernia repairs are one of the most frequently performed operations in the daily practice of pediatric surgeries.Regional anesthesia techniques are frequently and effectively used methods in postoperative pain control. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae plane block and caudal block in pediatric unilateral inguinal hernia operations

Conditions

Post Operative Pain; Inguinal Hernia

Keywords

Caudal block; Erector spinae block; Pediatric postoperative analgesia; Inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption

  Opioid consumption, need for rescue analgesic

  24 Hour

Secondary Outcomes (2)

• The Face, Legs, Activity, Cry and Consolability (FLACC) scale for pediatric pain evaluation.

  24 Hour

• Parental Satisfaction Assessment

  24 Hour

Study Arms (2)

ESP Group

EXPERIMENTAL

Erector Spinae Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks

Procedure: Erector Spinae Plane Block

Caudal Group

ACTIVE COMPARATOR

Caudal Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks

Procedure: Caudal Block

Interventions

Erector Spinae Plane Block PROCEDURE

Application of ultrasound-guided erector spinae plane block for perioperative analgesia for elective inguinal hernia repair. Erector spinae plane block will be administered under general anesthesia before the surgery Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc).

ESP Group

Caudal Block PROCEDURE

Application of caudal block for perioperative analgesia for elective inguinal hernia repair. The caudal block will be administered under general anesthesia before the surgery. Drug: Bupivacaine (Block Drug) 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for block performances

Also known as: Caudal Epidural Block

Caudal Group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patient scheduled for unilateral elective inguinal hernia operation
• ASA status 1-2

You may not qualify if:

• Pediatric patient's parents refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics,
• Bleeding diathesis,
• Severe kidney or liver disease
• Presence of infection at the needle entry site.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead
• Karabuk University: collaborator
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (7)

Abant İzzet Baysal Education and Training Hospital

Bolu, Merkez, Turkey (Türkiye)

RECRUITING

Bolu Abant İzzet Baysal Medical School

Bolu, 14030, Turkey (Türkiye)

RECRUITING

Bolu Abant İzzet Baysal University Faculty of Medicine

Bolu, 14030, Turkey (Türkiye)

RECRUITING

Karabuk University Karabuk Training and Research Hospital

Karabük, 78100, Turkey (Türkiye)

RECRUITING

Karabuk University Training and Research Hospital

Karabük, 78100, Turkey (Türkiye)

RECRUITING

Karabuk University Training and Research Hospital

Karabük, 78100, Turkey (Türkiye)

RECRUITING

Karabük University Training and Research Hospital

Karabük, 78100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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: 27501016 BACKGROUND

• Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.

  PMID: 30851499 RESULT

• Cosarcan SK, Mahli A. [Comparison of intraoperative and postoperative analgesic properties of ilioinguinal/iliohypogastric and sacral epidural block in pediatric unilateral inguinal hernia operations]. Agri. 2022 Jan;34(1):38-46. doi: 10.14744/agri.2021.48254. Turkish.

  PMID: 34988963 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Study Officials

• Kenan Kart, MD

  Karabuk University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Kasım İlker İtal

  Bolu Abant University Hospital

  STUDY DIRECTOR

• Duygu Taskin

  Karabuk University Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Kenan Kart, MD

CONTACT

+905337723300; kenankart@karabuk.edu.tr

Ilker Ital, MD

CONTACT

+905337723300; ilkerital@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 9, 2023
• Study Start: May 8, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (7)