Postoperative PainNCT04106687
Comparison Sacral Erector Spinae Block Versus Caudal Block
A study testing Ultrasound Guided Caudal Block and Sacral Erector Spinae Block in people with Postoperative Pain, run by Kahramanmaras Sutcu Imam University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 9 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound Guided Caudal Block and Sacral Erector Spinae Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 27 Sep 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 9 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Age 1-9
- ASA physical status I-II
- Undergoing unilateral low abdominal surgery
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Koç University Hospital
Istanbul
Kahramanmaras Sutcu Imam University Hospital
Kahramanmaraş
Kocaeli University Hospital
Kocaeli
About this study
Official title: A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children
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.
Read the 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
- Being tested
- Ultrasound Guided Caudal Block, Sacral Erector Spinae Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Caudal BlockProcedure or surgery
Postoperative pain procedure
Sacral Erector Spinae BlockProcedure or surgery
Postoperative pain procedure
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Procedure: Ultrasound Guided Caudal Block; Procedure: 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%. Receives: Procedure: Ultrasound Guided Caudal Block; Procedure: Sacral Erector Spinae Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of analgesic consumption
Acetaminophen and Fentanly
Measured: 24 hour
Secondary outcomes (2)
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
Measured: 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).
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start27 Sep 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Kocaeli University, Koç University
- Responsible party
- Principal investigator, Gözen Öksüz, Kahramanmaras Sutcu Imam University
- Investigators
- Can Aksu, M.D., Principal investigator, Kocaeli UniversityYavuz Gürkan, Professor, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106687
- Sponsor's protocol ID
- 2019/12-16
- Status last verified
- Feb 2020
- First submitted
- 25 Sep 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31491727Aksu 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.
PubMed 31203111
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children
- ClinicalTrials.gov ID
- NCT04106687
- Acronym / sponsor ID
- 2019/12-16
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Kocaeli University, Koç University
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
| Arm | Type | Receives |
|---|---|---|
| Caudal Block | Active comparator | Procedure: Ultrasound Guided Caudal Block, Procedure: Sacral Erector Spinae BlockAfter 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 | Procedure: Ultrasound Guided Caudal Block, Procedure: Sacral Erector Spinae BlockAfter 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%. |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-9
- ASA physical status I-II
- Undergoing unilateral low abdominal surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Caudal BlockPostoperative pain procedure | Procedure or surgery | Caudal Block, Sacral Erector Spinae Block |
| Sacral Erector Spinae BlockPostoperative pain procedure | Procedure or surgery | Caudal Block, Sacral Erector Spinae Block |
Primary outcome
Number of analgesic consumption
Time frame: 24 hour
Acetaminophen and Fentanly
2 secondary outcomes
Face, Legs, Activity, Cry and Consolability Score (FLACC)
Time frame: 24 hour
Parent satisfaction scores
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 31491727Oksuz 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.
- Background: PubMed 31203111Aksu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Can Aksu, M.D. principal investigator
Kocaeli University
Yavuz Gürkan, Professor principal investigator
Koç University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Caudal Block and Sacral Erector Spinae Block in people with Postoperative Pain, run by Kahramanmaras Sutcu Imam University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of analgesic consumption (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.