NCT04106687

Brief Summary

The purpose of this research study is to find the best way to decrease pain in children whom have had hypospadias surgery. Investigators will perform two technique; Caudal block or Sacral erector spinae block. The results of this study will help learn how to best control pain in children having surgery hypospadias surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

September 25, 2019

Last Update Submit

February 29, 2020

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Number of analgesic consumption

    Acetaminophen and Fentanly

    24 hour

Secondary Outcomes (2)

  • Face, Legs, Activity, Cry and Consolability Score (FLACC)

    24 hour

  • Parent satisfaction scores

    24 hour

Study Arms (2)

Caudal Block

ACTIVE COMPARATOR

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided caudal block wil performe with bupivacaine 1 ml/kg as 0.25%.

Procedure: Ultrasound Guided Caudal BlockProcedure: Sacral Erector Spinae Block

Sacral Erector Spinae Block

ACTIVE COMPARATOR

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided sacral erector spinae block wil performe with bupivacaine 1 ml/kg as 0.25%.

Procedure: Ultrasound Guided Caudal BlockProcedure: Sacral Erector Spinae Block

Interventions

Ultrasound Guided Caudal BlockPROCEDURE

Postoperative pain procedure

Caudal BlockSacral Erector Spinae Block
Sacral Erector Spinae BlockPROCEDURE

Postoperative pain procedure

Caudal BlockSacral Erector Spinae Block

Eligibility Criteria

Age1 Year - 9 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-9
  • ASA physical status I-II
  • Undergoing unilateral low abdominal surgery

You may not qualify if:

  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  • Parent refusal
  • History of allergic reactions to local anesthetics
  • Rash or infection at the injection site
  • Anatomical abnormality
  • Bleeding diatheses
  • Coagulopathy
  • History of diseases renal hepatic cardiac upper or lower airway neurologica

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Koç University Hospital

Istanbul, Turkey (Türkiye)

Location

Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, Turkey (Türkiye)

Location

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Location

Related Publications (2)

  • Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.

    PMID: 31491727BACKGROUND

  • Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.

    PMID: 31203111BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Can Aksu, M.D.

    Kocaeli University

    PRINCIPAL INVESTIGATOR

  • Yavuz Gürkan, Professor

    Koç University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

September 27, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

March 3, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(3)