Aortic CoarctationNCT06567275
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy
A study testing Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Aortic Coarctation, run by Cairo University at 1 site in Egypt.
Trial summary
Pain is considered to be subjective, however, in children, it is believed to be felt rather than expressed because they often depend on the caregiver for their safety and well-being. Read more about this study
- Who is it for?
- Ages 3 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Coarctation
- What is being tested?
- Erector Spinae Plane Block and Serratus Anterior Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2024to 15 Apr 2025
- 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 3 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 3 months-2 years.
- RACHS-1 score 3.
- Patients undergoing aortic coarctectomy operation with Lateral thoracotomy incision.
Who cannot join
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Perioperative cardiopulmonary arrested patients.
- Patients undergoing aortic coarctectomy operation with midline sternotomy incision.
- History of mental retardation or delayed development that may interfere with pain intensity assessment.
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- Known or suspected coagulopathy. (PT < 75% of control)
- Any congenital anomalies or any infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
- liver enzymes elevated more than the normal values.
- Renal function impairment (Creatinine value more than 1.2mg/dl or BUN more than 20mg/dl).
- Heart failure patients
- Redo patients and previous catheter dilatations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block in Pediatric Patients Undergoing Aortic Coarctectomy , a Randomized Controlled Study .
Pain is considered to be subjective, however, in children, it is believed to be felt rather than expressed because they often depend on the caregiver for their safety and well-being.
There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neurohormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for pediatric patients is mandatory.
Read more
The use of highly potent opioids for pediatric cardiothoracic anesthesia has gained widespread popularity during the last 20 years. In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery.
serratus anterior plane block guided by ultrasound was developed by Blanco et al, it is a novel technique in the management of pain following thoracic procedures.
Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks.
The Erector Spinae Plane Block (ESPB) is also one of the recently known pain-controlling techniques used in pediatric cardiothoracic surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks. Chin et al. documented the cadaveric spread of local anesthetic and noted that, radiologically, the local anesthetic spread extended 3 or 4 levels cranially and caudally from the site of injection.
These two blocks have been compared in a study by wang HJ et al in patients undergoing radical mastectomy.
To our knowledge, the comparison of serratus Plane Block versus erector spinae plane block in aortic coarctectomy operations in pediatric patients has not been investigated yet. This has encouraged the performance of the present study.
- Conditions
- Aortic Coarctation
- Being tested
- Erector Spinae Plane Block, Serratus Anterior Plane Block
- Keywords
- erector spinae plane block, serratus anterior plane block, aortic coarctectomy
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%)
Serratus Anterior Plane BlockProcedure or surgery
Ultrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%)
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block | Experimental | Ultrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). Receives: Procedure: Erector Spinae Plane Block |
| serratus anterior plane block | Experimental | Ultrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). Receives: Procedure: Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative fentanyl consumption by mcg/kg.
calculating the total dose of fentanyl used intraoperatively
Measured: Intra-operatively up to extubation
Secondary outcomes (5)
Time (in minutes) to 1st rescue analgesia (morphine)
estimating the time of the need for 1st dose of morphine which was given for pain scores ≥ 4
Measured: 1st 24 hours postoperatively
Heart rate and systolic blood pressure
recorded at 5 minutes after intubation (baseline value), before skin incision at 15 minutes after the block, after skin incision, after rib retraction, after aortic clamping, after aortic declamping, immediately after skin closure, and at 15 minutes after extubation
Measured: up to 15 minutes after extubation
The need and the dose of sodium nitroprusside after aortic clamping
sodium nitroprusside was given to control the hypertensive response to aortic clamping
Measured: from aortic clamping until removal of the clamps
total morphine dose
morphine was given for pain scores ≥ 4
Measured: up to 24 hours after surgery
Face, Legs, Activity, Cry, Consolability (FLACC) score
Postoperative pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) score every 2 hours for the first 24 hours postoperatively. If the FLACC score ≥ 4, 0.02 mg/kg morphine IV was administered as rescue analgesia to be repeated every 15-20 minutes till the pain score reaches < 4, not exceeding 0.2 mg/kg every 6 hours
Measured: up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start24 Aug 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic CoarctationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Awad Eissa Roman, Cairo University
- Investigators
- Wafaa M Elsadeq, Study director, Professor of Anesthesia, Pain Management, and Surgical ICU Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567275
- Sponsor's protocol ID
- Nerve blocks in coarctectomy
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gado AAM, Atia MAM, Roman AA, Elsadeq WM, Jaccoub VF. Analgesic efficacy of ultrasound guided erector spinae plane block versus serratus anterior plane block in pediatric patients undergoing aortic coarctectomy; a randomized controlled study. BMC Anesthesiol. 2025 Jul 30;25(1):370. doi: 10.1186/s12871-025-03256-y.
PubMed 40739624
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block in Pediatric Patients Undergoing Aortic Coarctectomy , a Randomized Controlled Study .
- ClinicalTrials.gov ID
- NCT06567275
- Acronym / sponsor ID
- Nerve blocks in coarctectomy
- Conditions
- Aortic Coarctation
- Keywords
- erector spinae plane block, serratus anterior plane block, aortic coarctectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 22 Aug 2024 (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.
Pain is considered to be subjective, however, in children, it is believed to be felt rather than expressed because they often depend on the caregiver for their safety and well-being.
There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neurohormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for pediatric patients is mandatory.
The use of highly potent opioids for pediatric cardiothoracic anesthesia has gained widespread popularity during the last 20 years. In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery.
serratus anterior plane block guided by ultrasound was developed by Blanco et al, it is a novel technique in the management of pain following thoracic procedures.
Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks.
The Erector Spinae Plane Block (ESPB) is also one of the recently known pain-controlling techniques used in pediatric cardiothoracic surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks. Chin et al. documented the cadaveric spread of local anesthetic and noted that, radiologically, the local anesthetic spread extended 3 or 4 levels cranially and caudally from the site of injection.
These two blocks have been compared in a study by wang HJ et al in patients undergoing radical mastectomy.
To our knowledge, the comparison of serratus Plane Block versus erector spinae plane block in aortic coarctectomy operations in pediatric patients has not been investigated yet. This has encouraged the performance of the present study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block | Experimental | Procedure: Erector Spinae Plane BlockUltrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). |
| serratus anterior plane block | Experimental | Procedure: Serratus Anterior Plane BlockUltrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). |
Who may qualify
- Ages
- 3 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 3 months-2 years.
- RACHS-1 score 3.
- Patients undergoing aortic coarctectomy operation with Lateral thoracotomy incision.
Key exclusion criteria (13 listed)
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Perioperative cardiopulmonary arrested patients.
- Patients undergoing aortic coarctectomy operation with midline sternotomy incision.
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 |
|---|---|---|
| Erector Spinae Plane BlockUltrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) | Procedure or surgery | erector spinae plane block |
| Serratus Anterior Plane BlockUltrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) | Procedure or surgery | serratus anterior plane block |
Primary outcome
Total intraoperative fentanyl consumption by mcg/kg.
Time frame: Intra-operatively up to extubation
calculating the total dose of fentanyl used intraoperatively
5 secondary outcomes
Time (in minutes) to 1st rescue analgesia (morphine)
Time frame: 1st 24 hours postoperatively
Heart rate and systolic blood pressure
Time frame: up to 15 minutes after extubation
The need and the dose of sodium nitroprusside after aortic clamping
Time frame: from aortic clamping until removal of the clamps
total morphine dose
Time frame: up to 24 hours after surgery
Face, Legs, Activity, Cry, Consolability (FLACC) score
Time frame: up to 24 hours after surgery
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 2 Jul 2025.
- Derived from this study: PubMed 40739624Gado AAM, Atia MAM, Roman AA, Elsadeq WM, Jaccoub VF. Analgesic efficacy of ultrasound guided erector spinae plane block versus serratus anterior plane block in pediatric patients undergoing aortic coarctectomy; a randomized controlled study. BMC Anesthesiol. 2025 Jul 30;25(1):370. doi: 10.1186/s12871-025-03256-y.
- 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.
Wafaa M Elsadeq study director
Professor of Anesthesia, Pain Management, and Surgical ICU Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Aortic Coarctation, run by Cairo University at 1 site in Egypt.
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 13 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 2 Jul 2025. 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 Egypt. 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 intraoperative fentanyl consumption by mcg/kg. (time frame: Intra-operatively up to extubation). 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 NCT06567275, which also lists 1 linked publication.
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 2 Jul 2025.