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

NCT04866368 | Unknown

• 1 other identifier: KSU 2019/12-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain; Analgesia

Keywords

Regional anaesthesia; Pediatric anesthesia; Erector spinae plane block; Penil block

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The erector spinae plane block

ACTIVE COMPARATOR

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.

Procedure: The ultrasound-guided Sacral Erector spinae plane block

The penile block

ACTIVE COMPARATOR

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.

Procedure: The dorsal penile block

Interventions

The ultrasound-guided Sacral Erector spinae plane block PROCEDURE

postoperative pain procedure

The erector spinae plane block

The dorsal penile block PROCEDURE

postoperative pain procedure

The penile block

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (2)

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Location

Kahramanmaras Sütcü Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: April 20, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 1, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

TU (2)