NCT05284734

Brief Summary

Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.

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 Jan 2021

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

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

March 9, 2022

Last Update Submit

March 9, 2022

Conditions

Keywords

UltrasoundPainCaudal blockErector spinae block

Outcome Measures

Primary Outcomes (1)

  • Level of Postoperative pain

    It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points. Following transfer from the recovery unit to the ward, the 1st, 2nd, 4th, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse.

    Up to 24 hours

Secondary Outcomes (2)

  • Time of Postoperative analgesic requirement

    Up to 24 hours

  • Rate of Postoperative complications

    Up to 24 hours

Study Arms (2)

Caudal block group

EXPERIMENTAL

A 22 gauge 50 mm echogenic block needle placed through the sacrococcygeal membrane into the sacral canal in the longitudinal position, using the in-plane technique Negative aspiration was then performed 0.125% bupivacaine at a dose of 1 ml/kg was administered

Procedure: Regional anesthesia intervention

Erector spinae block group

EXPERIMENTAL

The erector spinae muscle and the transverse process were identified, and a 22 G, 80 mm echogenic block needle was advanced towards the transverse process until contact. Following hydrodissection, 1 ml/kg of 0.125% bupivacaine was injected deep into the erector spinae muscle

Procedure: Regional anesthesia intervention

Interventions

Ultrasound-guided caudal and erector spinae blocks were administered

Caudal block groupErector spinae block group

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • ASA (American Society of Anesthesiologists) I-II group
  • Scheduled for circumcision and unilateral lower abdominal surgery at the same session
  • Able to communicate in Turkish
  • Willing to participate to the study (parents and children)

You may not qualify if:

  • Less than 1 or more than 7 years of age
  • A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
  • Unwilling to to participate to the study ((parents or children)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (4)

  • Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.

    PMID: 30868029BACKGROUND
  • Ozen V, Yigit D. A Comparison of the Postoperative Analgesic Effectiveness of Ultrasound-Guided Dorsal Penile Nerve Block and Ultrasound-Guided Pudendal Nerve Block in Circumcision. Urol Int. 2020;104(11-12):871-877. doi: 10.1159/000509173. Epub 2020 Aug 13.

    PMID: 32791500BACKGROUND
  • Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.

    PMID: 32507565BACKGROUND
  • Ozen V, Turan EI, Kirdan T, Ayas TA, Erten E, Karacalar S. Erector spinae plane block as an alternative to caudal block in concurrent pediatric urologic and inguinal surgery: A double-blinded randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e42109. doi: 10.1097/MD.0000000000042109.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Volkan Özen, Asso.Prof.

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 17, 2022

Study Start

January 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 15, 2021

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations