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

Not Applicable

• Conditions: Postoperative Pain; Analgesia
• Interventions: Procedure: The ultrasound-guided Sacral Erector spinae plane block; Procedure: The dorsal penile block

• Registration Number: NCT04866368
• Lead Sponsor: Kocaeli University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-02
• Primary Completion: 2022-04-20
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The erector spinae plane block	The ultrasound-guided Sacral 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.
The penile block	The dorsal 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.

Primary Outcome Measures

Name	Time	Method
FLACC score	during postoperative 24 hour	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.

Trial Locations

Locations (2)

Kahramanmaras Sütcü Imam University; 🇹🇷 Kahramanmaraş, Turkey

Kocaeli University Hospital; 🇹🇷 İzmit, Kocaeli, Turkey