Pediatric PatientsNCT04945694
Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery
A study testing Ultrasound-guided bilateral pecto-intercostal fascial block, Intravenous fentanyl and Propofol in people with Pediatric Patients and Congenital Heart Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site. In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pediatric Patients, Congenital Heart Surgery
- What is being tested?
- Ultrasound-guided bilateral pecto-intercostal fascial block, Intravenous fentanyl and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2021to Aug 2022
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- On pump
- Elective repair of congenital simple left to right intracardiac shunt
- Median sternotomy
Who cannot join
- Refusal of their guardians
- Redo cardiac surgery
- Previous back injury
- Previous back surgery
- Kyphoscoliosis
- Local infection of the skin and subcutaneous tissue at the site of needle puncture
Show all 13Show fewer
- Hypersensitivity to local anesthetics
- Coagulation disorders
- Renal disease
- Hepatic disease
- Pulmonary disease
- Heart failure
- Moderate to severe pulmonary hypertension.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University
Al Mansurah, DK, 050
Mohamed A Ghanem, MD, 00201067883998, mohamed.abdel_latif@yahoo.com
Enas Abd Elmotlb, MD, 00201005401236, sevo2006@gmail.com
About this study
Official title: Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study
Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.
In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.
Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.
Read the detailed description
The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.
- Conditions
- Pediatric Patients, Congenital Heart Surgery
- Being tested
- Ultrasound-guided bilateral pecto-intercostal fascial block, Intravenous fentanyl, Propofol, Sevoflurane, Atracurium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided bilateral pecto-intercostal fascial blockOther
- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED
Intravenous fentanylDrug
In this group, patients will receive only incremental doses of intravenous fentanyl
PropofolDrug
Propofol anesthesia
SevofluraneDrug
Sevoflurane anesthesia
AtracuriumDrug
Intravenous atracurium
ultrasoundDevice
ultrasound-guided block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided bilateral pecto-intercostal fascial block | Experimental | Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block Receives: Other: Ultrasound-guided bilateral pecto-intercostal fascial block; Drug: Propofol; Drug: Sevoflurane; Drug: Atracurium; Device: ultrasound |
| Intravenous fentanyl | Placebo comparator | Patients will receive only incremental doses of intravenous fentanyl Receives: Drug: Intravenous fentanyl; Drug: Propofol; Drug: Sevoflurane; Drug: Atracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment
Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
Measured: Postoperative day 1
Total dose of fentanyl requirements
Total dose of fentanyl requirements
Measured: intraoperative and 24 hrs postoperatively
Secondary outcomes (3)
Serum cortisol levels
Measured: Basal and one-hour postoperatively
Heart rate [HR]
Measured: before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Invasive mean arterial blood pressure [MAP]
Measured: before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study startAug 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric PatientsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Ghanem, MD, Study director, Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, EgyptEnas Abd Elmotlb, MD, Study chair, professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945694
- Sponsor's protocol ID
- MD/ 21.04.462
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De -identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04945694
- Acronym / sponsor ID
- MD/ 21.04.462
- Conditions
- Pediatric Patients, Congenital Heart Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 30 Jun 2021 (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.
Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.
In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.
Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.
Detailed description
The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided bilateral pecto-intercostal fascial block | Experimental | Other: Ultrasound-guided bilateral pecto-intercostal fascial block, Drug: Propofol, Drug: Sevoflurane, Drug: Atracurium, Device: ultrasoundPatients will receive bilateral ultrasound-guided pecto-intercostal fascial block |
| Intravenous fentanyl | Placebo comparator | Drug: Intravenous fentanyl, Drug: Propofol, Drug: Sevoflurane, Drug: AtracuriumPatients will receive only incremental doses of intravenous fentanyl |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- On pump
- Elective repair of congenital simple left to right intracardiac shunt
- Median sternotomy
Key exclusion criteria (13 listed)
- Refusal of their guardians
- Redo cardiac surgery
- Previous back injury
- Previous back surgery
- Kyphoscoliosis
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 bilateral pecto-intercostal fascial block- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED | Other | Ultrasound-guided bilateral pecto-intercostal fascial block |
| Intravenous fentanylIn this group, patients will receive only incremental doses of intravenous fentanyl | Drug | Intravenous fentanyl |
| PropofolPropofol anesthesia | Drug | Intravenous fentanyl, Ultrasound-guided bilateral pecto-intercostal fascial block |
| SevofluraneSevoflurane anesthesia | Drug | Intravenous fentanyl, Ultrasound-guided bilateral pecto-intercostal fascial block |
| AtracuriumIntravenous atracurium | Drug | Intravenous fentanyl, Ultrasound-guided bilateral pecto-intercostal fascial block |
| ultrasoundultrasound-guided block | Device | Ultrasound-guided bilateral pecto-intercostal fascial block |
Primary outcome
Postoperative pain assessment
Time frame: Postoperative day 1
Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
Total dose of fentanyl requirements
Time frame: intraoperative and 24 hrs postoperatively
Total dose of fentanyl requirements
3 secondary outcomes
Serum cortisol levels
Time frame: Basal and one-hour postoperatively
Heart rate [HR]
Time frame: before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Invasive mean arterial blood pressure [MAP]
Time frame: before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: Yes. De -identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Mohamed A Ghanem, MD study director
Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Enas Abd Elmotlb, MD study chair
professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
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 bilateral pecto-intercostal fascial block, Intravenous fentanyl and Propofol in people with Pediatric Patients and Congenital Heart Surgery, run by Mansoura 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: status not confirmed, as of the sponsor's last update on 30 Jun 2021. 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. Some participants in this study may receive a placebo. 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 Mohamed A Ghanem, MD' (00201067883998, mohamed.abdel_latif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessment (time frame: Postoperative day 1). The study lists 2 primary outcomes in all. 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 30 Jun 2021.