Clinical trial NCT04106687: Comparison Sacral Erector Spinae Block Versus Caudal Block
Official title: A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
Collaborators: name: Kocaeli University
name: Koç University
First posted: 2019-09-27
Enrollment: 44
Sex: MALE
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
Primary purpose: TREATMENT

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.

Detailed description: Children aged 1-9 years undergoing hypospadias surgeries would be recruited in this randomized study.

Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.

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 (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients.

Consenting patients scheduled to have hypospadias surgery will be randomised to sacral erector spinae block or caudal block at the begin of surgery.

All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will receive paracetamol if requirement for postoperative analgesia.All patient will transfer from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC score will be used.

Eligibility criteria: Inclusion Criteria:

1. Age 1-9
2. ASA physical status I-II
3. Undergoing unilateral low abdominal surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Number of analgesic consumption
timeFrame: 24 hour
Secondary outcomes:
measure: Face, Legs, Activity, Cry and Consolability Score (FLACC)
timeFrame: 24 hour
measure: Parent satisfaction scores
timeFrame: 24 hour
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Koç University Hospital
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
affiliation: Kocaeli University
name: Can Aksu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Koç University
name: Yavuz Gürkan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.