Comparison of Erector Spinae Plane Block and Penile Block in Hypospadias Surgery

NCT ID: NCT04866368

Last Updated: 2021-06-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-05-01

Brief Summary

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In this study, we aimed to compare ultrasound-guided sacral erector spinae plane block and dorsal penile block on postoperative analgesic effect in hypospadias surgery.

Detailed Description

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ASAI-II, 1-9 years old patients with hypospadias diagnosis and operated in Kahramanmaraş Sütçü İmam University hospital and Kocaeli University hospital were randomized with closed envelope technique and divided into two groups as penile block or erector spinae plane block. Erector spinae plane block or penile block application (by Gözen Öksüz, Can Aksu) will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. Vital signs such as pulse, sp02, blood pressure will be monitored before, during and at the end of the operation. At the end of the operation and after the patient is awakened 5. min., 30 min. 1., 2., 4., 6., 12., 24. hourly FLACC pain scores, number of analgesic use within 24 hours, patient family satisfaction (1: dissatisfied, 2: satisfied, 3: very satisfied), complication rates will be recorded.

Conditions

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Postoperative Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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The erector spinae plane block

The ultrasound-guided Erector spinae plane block (ESPB) with 1 ml/kg 0,25 % bupivacaine at the lumbar vertebral level will perform before surgery to all patients in the ESPB group.

Group Type ACTIVE_COMPARATOR

The ultrasound-guided Sacral Erector spinae plane block

Intervention Type PROCEDURE

postoperative pain procedure

The penile block

The penile block with 0,5ml/kg 0,25 % bupivacaine will be performed after the patients give standard general anesthesia and a laryngeal mask is applied.

Group Type ACTIVE_COMPARATOR

The dorsal penile block

Intervention Type PROCEDURE

postoperative pain procedure

Interventions

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The ultrasound-guided Sacral Erector spinae plane block

postoperative pain procedure

Intervention Type PROCEDURE

The dorsal penile block

postoperative pain procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaraş Sütçü İmam University Hospital and Kocaeli University Hospital

Exclusion Criteria

* American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site
Minimum Eligible Age

1 Year

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Can AKSU

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University Hospital

İzmit, Kocaeli, Turkey (Türkiye)

Site Status

Kahramanmaras Sütcü Imam University

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/31203111/

Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia?

Other Identifiers

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KSU 2019/12-17

Identifier Type: -

Identifier Source: org_study_id

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