Regional AnesthesiaNCT06089798
Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
An observational study of Regional Anesthesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to compare patients outcome in two groups. the first group will be applied pecto-intercostal fascial block additional to general anesthesia and the second group will not. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Regional Anesthesia
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Nov 2025
- Phase
- Observational
- 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 6 months to 12 years
- All sexes
- Child
Study population: Patients 6 months to 12 years old, undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass with ASA score 2 or 3.
Who may be able to join
- patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass.
- age between 6 months and 12 years
- ASA score 2 or 3
- Risk Adjustment for Congenital Heart Surgery (RACHS-1) score under 4
Who cannot join
- patients who need mechanical ventilation support before surgery
- patients who need to stay intubated more than 24 hours after surgery
- patients undergo complex cardiac surgery with RACHS-1 score higher than 4.
- patients without consent
- having allergic reaction to bupivacaine
- having cardiac surgery before (redo patient)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam and Sakura City Hospital
Istanbul, Basaksehir, 34480
Selin Sağlam, 0902129096000, selinsaglams@gmail.com
İncila Kahraman, 0902129096000, incilali@hotmail.com
About this study
Official title: Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Fascial Block in Pediatric Cardiac Surgery
The goal of this study is to compare patients outcome in two groups. the first group will be applied pecto-intercostal fascial block additional to general anesthesia and the second group will not.
This is a single-center, prospective, observational trial to study the efficacy of Pecto-intercostal Fascial Block (PIFB) in patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass. The children are aged between 6 months to 12 years with American Society of Anesthesiologists (ASA) score 2 or 3.
Read more
The main question it aims to answer are:
The investigators' first question is if applying pecto-intercostal fascial block just after anesthesia induction reduces postoperative pain status. Secondly, if this pain status makes any reduction in preoperative opioid consumption. The investigators aim to find out; if there is any difference in opioid consumption during operation and postoperative 24-hour, postoperative Face, Legs, Activity, Cry, Consolability (FLACC) scale, length of intensive care unit and hospital stays, and other complications.
- Conditions
- Regional Anesthesia
- Keywords
- pecto-intercostal fascial block, pediatric congenital cardiac surgery, postoperative pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PIFB Group | The patients in this group will be applied pecto-intercostal fascial block before surgical incision additional to general anesthesia. | |
| Nonblock Group | The patients in this group will be given only standard general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Face, Legs, Activity, Cry, Consolability scale (FLACC scale), FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. The values are between 0 and 10. The higher the score the worse the pain and outcome.
Measured: at the time of extubation, 1st hour after extubation, 2nd hour after extubation, 6th hour after extubation, 12th hour after extubation, 24th hour after extubation
Secondary outcomes (4)
peroperative opioid consumption
sum of fentanyl and remifentanil consumption in micrograms
Measured: during operation
Postoperative opioid consumption
morphine usage in milligrams
Measured: From extubation to 24 hours after extubation.
dexmedetomidine consumption
dexmedetomidine in micrograms
Measured: From the beginning of dexmedetomidine infusion to 24 hours after extubation
Paracetamol consumption
paracetamol in milligrams
Measured: From extubation to 24 hours after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selin Saglam, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089798
- Sponsor's protocol ID
- KAEK/2022.01.21
- Status last verified
- Oct 2023
- First submitted
- 11 Jun 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Fascial Block in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06089798
- Acronym / sponsor ID
- KAEK/2022.01.21
- Conditions
- Regional Anesthesia
- Keywords
- pecto-intercostal fascial block, pediatric congenital cardiac surgery, postoperative pain management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 18 Oct 2023 (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 goal of this study is to compare patients outcome in two groups. the first group will be applied pecto-intercostal fascial block additional to general anesthesia and the second group will not.
This is a single-center, prospective, observational trial to study the efficacy of Pecto-intercostal Fascial Block (PIFB) in patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass. The children are aged between 6 months to 12 years with American Society of Anesthesiologists (ASA) score 2 or 3.
The main question it aims to answer are:
The investigators' first question is if applying pecto-intercostal fascial block just after anesthesia induction reduces postoperative pain status. Secondly, if this pain status makes any reduction in preoperative opioid consumption. The investigators aim to find out; if there is any difference in opioid consumption during operation and postoperative 24-hour, postoperative Face, Legs, Activity, Cry, Consolability (FLACC) scale, length of intensive care unit and hospital stays, and other complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIFB Group | – | –The patients in this group will be applied pecto-intercostal fascial block before surgical incision additional to general anesthesia. |
| Nonblock Group | – | –The patients in this group will be given only standard general anesthesia. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients 6 months to 12 years old, undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass with ASA score 2 or 3.
Key inclusion criteria (4 listed)
- patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass.
- age between 6 months and 12 years
- ASA score 2 or 3
- Risk Adjustment for Congenital Heart Surgery (RACHS-1) score under 4
Key exclusion criteria (6 listed)
- patients who need mechanical ventilation support before surgery
- patients who need to stay intubated more than 24 hours after surgery
- patients undergo complex cardiac surgery with RACHS-1 score higher than 4.
- patients without consent
- having allergic reaction to bupivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Score
Time frame: at the time of extubation, 1st hour after extubation, 2nd hour after extubation, 6th hour after extubation, 12th hour after extubation, 24th hour after extubation
Face, Legs, Activity, Cry, Consolability scale (FLACC scale), FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. The values are between 0 and 10. The higher the score the worse the pain and outcome.
4 secondary outcomes
peroperative opioid consumption
Time frame: during operation
Postoperative opioid consumption
Time frame: From extubation to 24 hours after extubation.
dexmedetomidine consumption
Time frame: From the beginning of dexmedetomidine infusion to 24 hours after extubation
Paracetamol consumption
Time frame: From extubation to 24 hours after extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia, run by Başakşehir Çam & Sakura City Hospital at 1 site 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact selin sağlam (0905557198756, selinsaglams@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: at the time of extubation, 1st hour after extubation, 2nd hour after extubation, 6th hour after extubation, 12th hour after extubation, 24th hour after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2023.