Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia

NCT ID: NCT05284734

Last Updated: 2022-03-17

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

2021-01-01

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. 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. As far as we know, there is no previous study in the literature comparing CB and ESP block in pediatric patients.

Conditions

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Circumcision Lower Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Caudal block group

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

Group Type EXPERIMENTAL

Regional anesthesia intervention

Intervention Type PROCEDURE

Ultrasound-guided caudal and erector spinae blocks were administered

Erector spinae block group

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

Group Type EXPERIMENTAL

Regional anesthesia intervention

Intervention Type PROCEDURE

Ultrasound-guided caudal and erector spinae blocks were administered

Interventions

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Regional anesthesia intervention

Ultrasound-guided caudal and erector spinae blocks were administered

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1-7 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Volkan Ozen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Volkan Özen, Asso.Prof.

Role: PRINCIPAL_INVESTIGATOR

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Locations

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Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30868029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32791500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32507565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40228275 (View on PubMed)

Other Identifiers

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2021.42

Identifier Type: -

Identifier Source: org_study_id

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