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NCT04866368 Clinical Trial

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

Postoperative Pain Clinical Trial

Official title:
Comparison of Sacral Erector Spinae Plane Block and Dorsal Penile Block in Pain Management in Patients Undergoing Hypospadias Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04866368
Other study ID # KSU 2019/12-17
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 20, 2021
Est. completion date May 1, 2022

Study information
Verified date May 2021
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date May 1, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 9 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaras Sütçü Imam 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• The ultrasound-guided Sacral Erector spinae plane block
postoperative pain procedure
• The dorsal penile block
postoperative pain procedure

Locations
Country Name City State
Turkey Kocaeli University Hospital Izmit Kocaeli
Turkey Kahramanmaras Sütcü Imam University Kahramanmaras

Sponsors (1)
Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary FLACC score At the end of the operation and after the patient is awakened 5th min., 30th min., 1st, 2nd, 4th, 6th, 12th, 24th Hourly FLACC pain scores will be recorded. during postoperative 24 hour
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