Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children

NCT ID: NCT06373185

Last Updated: 2024-07-22

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

2024-04-22

Study Completion Date

2024-07-18

Brief Summary

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The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

Detailed Description

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The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.

Conditions

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Urogenital Diseases Nerve Block Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled double blind study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed.

Study Groups

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SESPB

Participants received ultrasound-guided SESPB before the surgery

Group Type EXPERIMENTAL

Ultrasound-guided sacral erector spinae plane block

Intervention Type PROCEDURE

Patients were received ultrasound-guided sacral erector spinae plane block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

CAUDAL

Participants received ultrasound-guided caudal block before the surgery

Group Type ACTIVE_COMPARATOR

Ultrasound-guided caudal block

Intervention Type PROCEDURE

Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

Interventions

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Ultrasound-guided sacral erector spinae plane block

Patients were received ultrasound-guided sacral erector spinae plane block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

Intervention Type PROCEDURE

Ultrasound-guided caudal block

Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 1-7 years undergoing paediatric urogenital surgery
* Patients in American Society of Anesthesiologist (ASA) class I-II

Exclusion Criteria

* Patients whose parents do not give consent
* Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
* Patients with known local anaesthetic allergy
* Patients for whom regional anaesthesia is contraindicated
* Known neurological or muscular disease
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Bilge Olgun Keles

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bilge Olgun Keleş

Role: PRINCIPAL_INVESTIGATOR

Giresun University

Dilek Yeniay

Role: STUDY_CHAIR

Giresun University

Elvan Tekir Yılmaz

Role: STUDY_CHAIR

Giresun University

İlke Tamdoğan

Role: STUDY_CHAIR

Giresun University

Mehmet Değermenci

Role: STUDY_CHAIR

Giresun University

Locations

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Giresun Research and Training Hospital

Giresun, Central, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/21

Identifier Type: -

Identifier Source: org_study_id

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