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| Name | Class |
|---|---|
| Kocaeli University | OTHER |
| Koç University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Guided Caudal Block | Procedure | Postoperative pain procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of analgesic consumption | Acetaminophen and Fentanly | 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Face, Legs, Activity, Cry and Consolability Score (FLACC) | FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. FLACC scale will be recorded at postoperative 30 minute, 1,2,4,6,12,24 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Can Aksu, M.D. | Kocaeli University | Principal Investigator |
| Yavuz Gürkan, Professor | Koç University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University Hospital | Istanbul | Turkey (Türkiye) | ||||
| Kahramanmaras Sutcu Imam University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31491727 | Background | 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. | |
| 31203111 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
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| Sacral Erector Spinae Block | Procedure | Postoperative pain procedure |
|
| 24 hour |
| Parent satisfaction scores | By investigators until hospital discharge, then through telephone interview with parents after that. Will be scored between 1-3 (1- very bad, 2-good, 3-very good). | 24 hour |
| Kahramanmaraş |
| Turkey (Türkiye) |
| Kocaeli University Hospital | Kocaeli | Turkey (Türkiye) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |