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

Primary Purpose

Postoperative Pain, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The ultrasound-guided Sacral Erector spinae plane block
The dorsal penile block
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Regional anaesthesia, Pediatric anesthesia, Erector spinae plane block, Penil block

Eligibility Criteria

1 Year - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kocaeli University Hospital
  • Kahramanmaras Sütcü Imam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The erector spinae plane block

The penile block

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
May 29, 2021
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT04866368
Brief Title
Comparison of Erector Spinae Plane Block and Penile Block in Hypospadias Surgery
Official Title
Comparison of Sacral Erector Spinae Plane Block and Dorsal Penile Block in Pain Management in Patients Undergoing Hypospadias Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Analgesia
Keywords
Regional anaesthesia, Pediatric anesthesia, Erector spinae plane block, Penil block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The erector spinae plane block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The penile block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
The ultrasound-guided Sacral Erector spinae plane block
Intervention Description
postoperative pain procedure
Intervention Type
Procedure
Intervention Name(s)
The dorsal penile block
Intervention Description
postoperative pain procedure
Primary Outcome Measure Information:
Title
FLACC score
Description
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.
Time Frame
during postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kocaeli University Hospital
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41340
Country
Turkey
Facility Name
Kahramanmaras Sütcü Imam University
City
Kahramanmaraş
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31203111/
Description
Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia?

Learn more about this trial

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

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