Aortic CoarctationPhase 3NCT04128540
Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy
A Phase 3 study testing Fentanyl and Erector spinae plane block in people with Aortic Coarctation and Erector Spinae Plane Block, 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 to 12 months
- Conditions the study is for
- Aortic Coarctation, Erector Spinae Plane Block, Paediatric
- What is being tested?
- Fentanyl and Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Jul 2021
- Phase
- Phase 3
- 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 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 3 months-12 months.
- A III .
- Patients undergoing aortic coarcitectomy operation undergone with Lateral thoracotomy incision.
Who cannot join
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Patients undergoing aortic coarctectomy operation undergone with midline sternotomy incision.
- Known or suspected coagulopathy.
- Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
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- Known or suspected allergy to any of the studied drugs.
- Elevated liver enzymesmore than the normal values.
- Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen more than 20mg/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy. 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, it will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neuro-hormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for paediatric patients is mandatory.
Read more
The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years.In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery.
Erector Spinae Plane Block (ESPB), recently developed by Forero et al, is a novel technique in management of thoracic neuropathic pain guided by ultrasound. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block.
To our knowledge, Erector Spinae Plane Block (ESPB) performed in aortic coarcitectomy operations has not been investigated yet.This has encouraged the performance of the present study.
Read the detailed description
Our study will be designed to estimate and compare the analgesic effect of single shot erector spinae plane block in pediatric patients undergoing aortic coarcitectomy via thoracotomy incision versus fentanyl infusion as the control group. Our primary outcome will be the total dose of intraoperative fentanyl bouluses.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESPB in patients included within the block group. this expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
The study will be conducted in the pediatric cardiothoracic operation theatre in Abu El Reesh Pediatric Hospital -Cairo University on 28 pediatric patients aged 3 months-12 months, ASA III undergoing aortic coarcitectomy (with thoracotomy incision).
All patients will attend at the pre- anesthesia room with their parents 1 hour before the procedure after taking approval of research ethical comittee and informed consent.
Detailed history from the parents will be taken followed by a full and detailed clinical examination of the child then all investigations including CBC, coagulation profile, liver enzymes, kidney function tests, Chest x-ray ,echocardiography and blood grouping will be checked.
ECG, pulse oximetry and non-invasive blood pressure will be applied to all patients. All patients will be premedicated by intramuscular midazolam 2mg/Kg and atropine 0.2 mg/Kg 20 minutes before induction of anesthesia.
Anesthesia will be induced in all patients by sevoflurane 5% in 100% O2 followed by Placement of peripheral I.V cannula and IV administration of fentanyl (1-2µg/kg). Oral endotracheal intubation will be facilitated by IV atracurium 0.5 mg/kg and then capnogram will be connected to monitor End-tidal CO2 and muscle relaxation will be maintained by atracurium infusion in a dose of 0.5 mg/ kg/ hr.
All patients will be mechanically ventilated using pressure controlled mode with FiO2 50%, positive end expiratory pressure (PEEP) 5 cmH2O,I: E ratio of 1:2,peak inspiratory pressure (PIP) will be set to deliver a tidal volume of 6-8 ml/kg and respiratory rate will be 15 to 35 cycle / minute according to the age. our aim is to keep end tidal CO2 between 30-40 mmHg.
Sevoflurane will be used for maintenance of anaesthesia and its MAC will be determined by using bispectoral index (targeting 40-60) to standardize the depth of anaesthesia.
After insertion of a central venous catheter and an arterial cannula , nasopharyngeal temperature probe will be placed and the patient's position will be changed from supine to right lateral position.
- Conditions
- Aortic Coarctation, Erector Spinae Plane Block, Paediatric
- Being tested
- Fentanyl, Erector spinae plane block
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
fentanyl infusion at a dose of (1 μg/kg/hour) after induction of anesthesia and to be continued all through the whole operation.rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group, if either systolic blood pressure or heart rate increased more than 20% of the baseline readings.
Erector spinae plane blockProcedure or surgery
ultrasound guided erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed at the same side of the planned thoracotomy under strict aseptic precautions.A high frequency 12 MHz linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
Three muscles; trapezius, rhomboids major, and erector spinae will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalic direction, until the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | This group will receive fentanyl infusion only Receives: Drug: Fentanyl |
| ESPB group | Active comparator | This group will receive fentanyl infusion plus Ultrasound guided ESPB Receives: Drug: Fentanyl; Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of intraoperative fentanyl boluses.
microgram/kg
Measured: From skin incision till 5 minutes after skin closure
Secondary outcomes (2)
Face, Leg, Activity, Cry, Consolability
- Face
- 0: if patient has a relaxed face
- 1: if patient has a worried look ,eyes partially closed, mouth pursed
- 2: if patient has deep furrows in the forehead, with closed eyes, open mouth.
- Legs
- 0: if patient has usual tone and motion to limbs.
- 1: if patient has increase tone, rigidity.
- 2: if patient has hyper tonicity, legs pulled tight, exaggerated flexion/extension of limbs.
- Activity
- 0: if patient moves easily and freely.
- 1: if patient shifts positions, guarding.
- 2:if patient is in fixed position, side-to-side head movement.
- Cry
- 0: if patient has no cry/moan awake or asleep
- 1: if patient has occasional moans, cries.
- 2: if patient has frequent/continuous moans, cries, grunts.
- Consolability
- 0: if patient is calm and does not require consoling
- 1: if patient responds to comfort by touch or talk in ½- 1 minute
- 2: if patient requires constant comforting or unable to console.
Measured: 30 min, 60 min, 2 hours, 4hours, 8hours, 16hours and 24 hours postoperatively
postoperative Morphine
mg/kg
Measured: 30 minutes postoperative till 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Feb 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Kamal Harees Abdo, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128540
- Sponsor's protocol ID
- MD-213-2019
- Status last verified
- Jul 2022
- First submitted
- 15 Oct 2019
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy. a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04128540
- Acronym / sponsor ID
- MD-213-2019
- Conditions
- Aortic Coarctation, Erector Spinae Plane Block, Paediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 16 Oct 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.
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, it will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neuro-hormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for paediatric patients is mandatory.
The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years.In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery.
Erector Spinae Plane Block (ESPB), recently developed by Forero et al, is a novel technique in management of thoracic neuropathic pain guided by ultrasound. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block.
To our knowledge, Erector Spinae Plane Block (ESPB) performed in aortic coarcitectomy operations has not been investigated yet.This has encouraged the performance of the present study.
Detailed description
Our study will be designed to estimate and compare the analgesic effect of single shot erector spinae plane block in pediatric patients undergoing aortic coarcitectomy via thoracotomy incision versus fentanyl infusion as the control group. Our primary outcome will be the total dose of intraoperative fentanyl bouluses.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESPB in patients included within the block group. this expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
The study will be conducted in the pediatric cardiothoracic operation theatre in Abu El Reesh Pediatric Hospital -Cairo University on 28 pediatric patients aged 3 months-12 months, ASA III undergoing aortic coarcitectomy (with thoracotomy incision).
All patients will attend at the pre- anesthesia room with their parents 1 hour before the procedure after taking approval of research ethical comittee and informed consent.
Detailed history from the parents will be taken followed by a full and detailed clinical examination of the child then all investigations including CBC, coagulation profile, liver enzymes, kidney function tests, Chest x-ray ,echocardiography and blood grouping will be checked.
ECG, pulse oximetry and non-invasive blood pressure will be applied to all patients. All patients will be premedicated by intramuscular midazolam 2mg/Kg and atropine 0.2 mg/Kg 20 minutes before induction of anesthesia.
Anesthesia will be induced in all patients by sevoflurane 5% in 100% O2 followed by Placement of peripheral I.V cannula and IV administration of fentanyl (1-2µg/kg). Oral endotracheal intubation will be facilitated by IV atracurium 0.5 mg/kg and then capnogram will be connected to monitor End-tidal CO2 and muscle relaxation will be maintained by atracurium infusion in a dose of 0.5 mg/ kg/ hr.
All patients will be mechanically ventilated using pressure controlled mode with FiO2 50%, positive end expiratory pressure (PEEP) 5 cmH2O,I: E ratio of 1:2,peak inspiratory pressure (PIP) will be set to deliver a tidal volume of 6-8 ml/kg and respiratory rate will be 15 to 35 cycle / minute according to the age. our aim is to keep end tidal CO2 between 30-40 mmHg.
Sevoflurane will be used for maintenance of anaesthesia and its MAC will be determined by using bispectoral index (targeting 40-60) to standardize the depth of anaesthesia.
After insertion of a central venous catheter and an arterial cannula , nasopharyngeal temperature probe will be placed and the patient's position will be changed from supine to right lateral position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: FentanylThis group will receive fentanyl infusion only |
| ESPB group | Active comparator | Drug: Fentanyl, Procedure: Erector spinae plane blockThis group will receive fentanyl infusion plus Ultrasound guided ESPB |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 3 months-12 months.
- A III .
- Patients undergoing aortic coarcitectomy operation undergone with Lateral thoracotomy incision.
Key exclusion criteria (9 listed)
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Patients undergoing aortic coarctectomy operation undergone with midline sternotomy incision.
- Known or suspected coagulopathy.
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 |
|---|---|---|
| Fentanylfentanyl infusion at a dose of (1 μg/kg/hour) after induction of anesthesia and to be continued all through the whole operation.rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group, if either systolic blood pressure or heart rate increased more than 20% of the baseline readings. | Drug | Control group, ESPB group |
| Erector spinae plane blockultrasound guided erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed at the same side of the planned thoracotomy under strict aseptic precautions.A high frequency 12 MHz linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius, rhomboids major, and erector spinae will be identified superior to the hyperechoic transverse process. Using in-plane approach a 25 G needle will be inserted in caudal-cephalic direction, until the tip is deep to erector spinae muscle. Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process.. | Procedure or surgery | ESPB group |
Primary outcome
The total dose of intraoperative fentanyl boluses.
Time frame: From skin incision till 5 minutes after skin closure
microgram/kg
2 secondary outcomes
Face, Leg, Activity, Cry, Consolability
Time frame: 30 min, 60 min, 2 hours, 4hours, 8hours, 16hours and 24 hours postoperatively
postoperative Morphine
Time frame: 30 minutes postoperative till 24 hours postoperative
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 8 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing Fentanyl and Erector spinae plane block in people with Aortic Coarctation and Erector Spinae Plane Block, 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 9 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 8 Jul 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The total dose of intraoperative fentanyl boluses. (time frame: From skin incision till 5 minutes after skin closure). 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 8 Jul 2022.