Congenital Heart DiseaseNCT07740915
Comparison of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block for Postoperative Analgesia in Pediatric Cardiac Surgery
A study testing Ultrasound-Guided Erector Spinae Plane Block and Ultrasound-Guided Modified Pectoral Fascial Plane Block in people with Congenital Heart Disease and Postoperative Pain After Cardiac Surgery Via Median Sternotomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB), are increasingly used as part of multimodal analgesia; however… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- What is being tested?
- Ultrasound-Guided Erector Spinae Plane Block and Ultrasound-Guided Modified Pectoral Fascial Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2026to 10 Oct 2026
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients younger than 18 years of age.
- Scheduled for first-time elective congenital cardiac surgery.
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Redo cardiac surgery.
- Emergency surgery.
- Contraindication to regional fascial plane block (e.g., infection at the injection site or allergy to local anesthetics).
- Coagulopathy.
- Chronic liver disease.
- Renal failure.
- History of opioid use before surgery.
- Failure to obtain written informed consent from a parent or legal guardian.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Gazi Yasargil TRH
Diyarbakır, Diyarbakır, 210070
About this study
Official title: Comparison of the Analgesic Effects of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block in Pediatric Cardiac Surgery: A Randomized Controlled Trial
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB), are increasingly used as part of multimodal analgesia; however, evidence directly comparing these techniques in pediatric cardiac surgery remains limited.
This prospective randomized controlled study aims to compare the analgesic efficacy of ESPB and M-PFPB in pediatric patients undergoing elective congenital cardiac surgery. The primary objective is to identify the regional anesthesia technique associated with more effective postoperative pain control. Secondary objectives include comparison of perioperative opioid consumption, hemodynamic parameters, extubation time, postoperative pain scores, perioperative complications, and intensive care unit and hospital length of stay. The findings are expected to contribute to the optimization of perioperative analgesia protocols and improve postoperative recovery in pediatric cardiac surgery.
Read the detailed description
Effective postoperative analgesia is a key determinant of recovery following pediatric congenital cardiac surgery. Adequate pain control may reduce opioid requirements, facilitate early extubation, decrease perioperative complications, and improve overall postoperative outcomes. Among the regional anesthesia techniques used in pediatric cardiac surgery, erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB) have gained increasing attention because of their potential to provide effective analgesia while minimizing opioid exposure.
This prospective randomized controlled trial is designed to compare the analgesic efficacy of ESPB and M-PFPB in pediatric patients undergoing first-time elective congenital cardiac surgery. Patients younger than 18 years who meet the eligibility criteria will be enrolled after written informed consent has been obtained from their parents or legal guardians.
Demographic characteristics, including age, sex, body mass index, ASA physical status, and cardiac diagnosis, will be recorded. Perioperative variables, including cardiopulmonary bypass duration, aortic cross-clamp time, duration of surgery, duration of anesthesia, intraoperative and postoperative opioid consumption, intraoperative hemodynamic parameters (heart rate, blood pressure, near-infrared spectroscopy, and oxygen saturation), extubation time, postoperative FLACC pain scores, perioperative complications, intensive care unit length of stay, and hospital length of stay, will be prospectively collected and analyzed.
The primary objective of the study is to determine which regional anesthesia technique provides more effective postoperative analgesia in pediatric congenital cardiac surgery. Secondary objectives include comparison of opioid requirements, postoperative recovery parameters, and perioperative complications between the two study groups. The study findings are expected to support the development of evidence-based perioperative analgesia protocols for pediatric cardiac surgery and contribute to the current literature.
- Conditions
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- Being tested
- Ultrasound-Guided Erector Spinae Plane Block, Ultrasound-Guided Modified Pectoral Fascial Plane Block
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block will be performed bilaterally after induction of general anesthesia and before surgical incision to provide postoperative analgesia in pediatric patients undergoing congenital cardiac surgery.
Ultrasound-Guided Modified Pectoral Fascial Plane BlockProcedure or surgery
Ultrasound-guided modified pectoral fascial plane block will be performed bilaterally after induction of general anesthesia and before surgical incision to provide postoperative analgesia in pediatric patients undergoing congenital cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Participants randomized to this group will receive an ultrasound-guided erector spinae plane block (ESPB) as part of multimodal perioperative analgesia before elective congenital cardiac surgery. Standard perioperative anesthesia and postoperative analgesia protocols will be applied to all participants Receives: Procedure: Ultrasound-Guided Erector Spinae Plane Block |
| Modified Pectoral Fascial Plane Block | Active comparator | Participants randomized to this group will receive an ultrasound-guided modified pectoral fascial plane block (M-PFPB) as part of multimodal perioperative analgesia before elective congenital cardiac surgery. Standard perioperative anesthesia and postoperative analgesia protocols will be applied to all participants. Receives: Procedure: Ultrasound-Guided Modified Pectoral Fascial Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Opioid Consumption
Total opioid consumption during the first 24 hours after surgery will be recorded and compared between the Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) groups.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Time to Extubation
The time from the end of surgery until successful tracheal extubation will be recorded.
Measured: From the end of surgery up to 48 hours postoperatively
Postoperative FLACC Pain Scores
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. FLACC scores will be recorded prospectively and compared between the Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) groups
Measured: Assessed at 0, 1, 2, 4, 8, 12, 18, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start30 Jul 2026
- Primary completion5 Oct 2026
- Study completion10 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- This is a prospective, randomized, parallel-group, single-center clinical trial comparing the analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) in pediatric patients undergoing elective congenital cardiac surgery. Eligible participants will be randomly assigned in a 1:1 ratio to one of the two intervention groups. Clinical outcomes will be prospectively evaluated and compared between the groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Bıçak, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740915
- Sponsor's protocol ID
- 306
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.
PubMed 32859487Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.
PubMed 31515190Macaire P, Ho N, Nguyen V, Phan Van H, Dinh Nguyen Thien K, Bringuier S, Capdevila X. Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2020 Oct;45(10):805-812. doi: 10.1136/rapm-2020-101496. Epub 2020 Aug 19.
PubMed 32817407
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block in Pediatric Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07740915
- Acronym / sponsor ID
- 306
- Conditions
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 5 Oct 2026 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 3 Aug 2026 (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.
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB), are increasingly used as part of multimodal analgesia; however, evidence directly comparing these techniques in pediatric cardiac surgery remains limited.
This prospective randomized controlled study aims to compare the analgesic efficacy of ESPB and M-PFPB in pediatric patients undergoing elective congenital cardiac surgery. The primary objective is to identify the regional anesthesia technique associated with more effective postoperative pain control. Secondary objectives include comparison of perioperative opioid consumption, hemodynamic parameters, extubation time, postoperative pain scores, perioperative complications, and intensive care unit and hospital length of stay. The findings are expected to contribute to the optimization of perioperative analgesia protocols and improve postoperative recovery in pediatric cardiac surgery.
Detailed description
Effective postoperative analgesia is a key determinant of recovery following pediatric congenital cardiac surgery. Adequate pain control may reduce opioid requirements, facilitate early extubation, decrease perioperative complications, and improve overall postoperative outcomes. Among the regional anesthesia techniques used in pediatric cardiac surgery, erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB) have gained increasing attention because of their potential to provide effective analgesia while minimizing opioid exposure.
This prospective randomized controlled trial is designed to compare the analgesic efficacy of ESPB and M-PFPB in pediatric patients undergoing first-time elective congenital cardiac surgery. Patients younger than 18 years who meet the eligibility criteria will be enrolled after written informed consent has been obtained from their parents or legal guardians.
Demographic characteristics, including age, sex, body mass index, ASA physical status, and cardiac diagnosis, will be recorded. Perioperative variables, including cardiopulmonary bypass duration, aortic cross-clamp time, duration of surgery, duration of anesthesia, intraoperative and postoperative opioid consumption, intraoperative hemodynamic parameters (heart rate, blood pressure, near-infrared spectroscopy, and oxygen saturation), extubation time, postoperative FLACC pain scores, perioperative complications, intensive care unit length of stay, and hospital length of stay, will be prospectively collected and analyzed.
The primary objective of the study is to determine which regional anesthesia technique provides more effective postoperative analgesia in pediatric congenital cardiac surgery. Secondary objectives include comparison of opioid requirements, postoperative recovery parameters, and perioperative complications between the two study groups. The study findings are expected to support the development of evidence-based perioperative analgesia protocols for pediatric cardiac surgery and contribute to the current literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-group, single-center clinical trial comparing the analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) in pediatric patients undergoing elective congenital cardiac surgery. Eligible participants will be randomly assigned in a 1:1 ratio to one of the two intervention groups. Clinical outcomes will be prospectively evaluated and compared between the groups.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Ultrasound-Guided Erector Spinae Plane BlockParticipants randomized to this group will receive an ultrasound-guided erector spinae plane block (ESPB) as part of multimodal perioperative analgesia before elective congenital cardiac surgery. Standard perioperative anesthesia and postoperative analgesia protocols will be applied to all participants |
| Modified Pectoral Fascial Plane Block | Active comparator | Procedure: Ultrasound-Guided Modified Pectoral Fascial Plane BlockParticipants randomized to this group will receive an ultrasound-guided modified pectoral fascial plane block (M-PFPB) as part of multimodal perioperative analgesia before elective congenital cardiac surgery. Standard perioperative anesthesia and postoperative analgesia protocols will be applied to all participants. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients younger than 18 years of age.
- Scheduled for first-time elective congenital cardiac surgery.
- Written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (8 listed)
- Redo cardiac surgery.
- Emergency surgery.
- Contraindication to regional fascial plane block (e.g., infection at the injection site or allergy to local anesthetics).
- Coagulopathy.
- Chronic liver disease.
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 Erector Spinae Plane BlockUltrasound-guided erector spinae plane block will be performed bilaterally after induction of general anesthesia and before surgical incision to provide postoperative analgesia in pediatric patients undergoing congenital cardiac surgery. | Procedure or surgery | Erector Spinae Plane Block |
| Ultrasound-Guided Modified Pectoral Fascial Plane BlockUltrasound-guided modified pectoral fascial plane block will be performed bilaterally after induction of general anesthesia and before surgical incision to provide postoperative analgesia in pediatric patients undergoing congenital cardiac surgery. | Procedure or surgery | Modified Pectoral Fascial Plane Block |
Primary outcome
Total Postoperative Opioid Consumption
Time frame: 24 hours postoperatively
Total opioid consumption during the first 24 hours after surgery will be recorded and compared between the Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) groups.
2 secondary outcomes
Time to Extubation
Time frame: From the end of surgery up to 48 hours postoperatively
Postoperative FLACC Pain Scores
Time frame: Assessed at 0, 1, 2, 4, 8, 12, 18, and 24 hours postoperatively
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 13 Oct 2026.
- Background: PubMed 32859487Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.
- Background: PubMed 31515190Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.
- Background: PubMed 32817407Macaire P, Ho N, Nguyen V, Phan Van H, Dinh Nguyen Thien K, Bringuier S, Capdevila X. Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2020 Oct;45(10):805-812. doi: 10.1136/rapm-2020-101496. Epub 2020 Aug 19.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Erector Spinae Plane Block and Ultrasound-Guided Modified Pectoral Fascial Plane Block in people with Congenital Heart Disease and Postoperative Pain After Cardiac Surgery Via Median Sternotomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 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 13 Oct 2026. 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?
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?
Total Postoperative Opioid Consumption (time frame: 24 hours postoperatively). 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 NCT07740915, which also lists 3 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 13 Oct 2026.