NCT04106687

Comparison Sacral Erector Spinae Block Versus Caudal Block

A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Kahramanmaras Sutcu Imam University · Academic / Other
• Sex: Male
• Age: 1 Year – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Ultrasound Guided Caudal Block	Postoperative pain procedure
PROCEDURE	Sacral Erector Spinae Block	Postoperative pain procedure

Timeline

• Start date: 2019-09-27
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2019-09-27
• Last updated: 2020-03-03

Locations

3 sites across 1 country: Turkey (Türkiye)