Postoperative PainNCT06882655
A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery.
A study testing PIFB group, Intrathecal fentanyl(IT fentanyl) and IT + PIFB in people with Postoperative Pain and Pediatric Open Heart Surgery, run by Alexandria University at 2 sites in Egypt.
Trial summary
Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Postoperative Pain, Pediatric Open Heart Surgery
- What is being tested?
- PIFB group, Intrathecal fentanyl(IT fentanyl) and IT + PIFB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Apr 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The enrolled patients ranged in age from 6 months to 6 years,
- patients scheduled for surgical repair of congenital heart defects.
Who cannot join
- The preoperative criteria include a history of previous cardiac surgery, hemodynamic instability, the need for mechanical ventilation, and the requirement for vasoactive drugs, opioids, or corticosteroids.
- During the intraoperative phase, who use of deep hypothermic circulatory arrest and the necessity for vasoactive drugs, excluding the temporary use of dopamine and dobutamine at a maximum dose of 10 µg/kg/min.
- Postoperative exclusion conditions will include prolonged mechanical ventilation lasting more than 24 hours, hemodynamic instability, and the need for high doses of opioids or sedatives.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, 21521
Hesham ELgoweini, Prof.Dr., 00201287740750, ethics.comm@alexmed.edu.eg
Islam Elbardan, Dr
Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, 21521
About this study
Official title: A Combination of Intrathecal Fentanyl and Ultrasound-Guided Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery: A Randomized Controlled Trial
Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Recently, thoracic myofascial plane blocks with ultrasound guidance as part of multimodal analgesia have contributed to a faster recovery after surgery.
De la Torre et al. first described pectointercostal fascial plane block (PIFPB) for breast surgery. Local anaesthetics are injected between the pectoralis major and internal intercostal muscles close to the sternum to block the anterior cutaneous branch of the second-to-sixth thoracic intercostal nerves.The use of intrathecal (IT) opioids with or without local anaesthetics (LA) is a popular analgesic technique around the world for the management of postoperative pain. Unlike IT administration of LA, IT opioids produce 'segmental' analgesia and are not associated with muscle weakness, loss of proprioception or sympathetic block. IT opioids can be administered as an adjunct to general anaesthesia or combined with LA and administered during spinal anaesthesia for surgery. It is one of the easiest, most reliable and cost-effective methods for pain relief. Intrathecal opioid administration can provide more intense analgesia than the IV route and has the advantages of simplicity and reliability
Read the detailed description
Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Sternal wound pain has been linked to diminished patient satisfaction, delirium, and a spectrum of cardiovascular complications, including hypotension, tachycardia, arrhythmias, and respiratory issues such as stasis of bronchial secretions, atelectasis, and pneumonia.
Pain management after cardiac surgery is critical to enhancing recovery. Various modalities are available for managing postoperative pain in cardiac surgery. These modalities include opioids, local anaesthetic techniques such as local anaesthetic infiltration, and neuraxial blocks (epidural and paravertebral). Additionally, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are feasible options for pain control. Furthermore, adjunct analgesics such as steroids, ketamine, α2 agonists, and anticonvulsants are also employed for effective pain management.Opioids can elicit various adverse effects, such as delayed tracheal extubation, respiratory depression, sedation, ileus, nausea, vomiting, immunosuppression, cough suppression, drowsiness, and an increased risk of chronic pain.
Recently, thoracic myofascial plane blocks with ultrasound guidance as part of multimodal analgesia have contributed to a faster recovery after surgery.
De la Torre et al.first described pectointercostal fascial plane block (PIFPB) for breast surgery. Local anaesthetics are injected between the pectoralis major and internal intercostal muscles close to the sternum to block the anterior cutaneous branch of the second-to-sixth thoracic intercostal nerves. PIFPB has been an effective technique for pain control after sternotomy . However, a high incidence of non-sternal wound pain was observed with this technique of fascial plain block both in adults and paediatrics after cardiac surgery .
The use of intrathecal (IT) opioids with or without local anaesthetics (LA) is a popular analgesic technique around the world for the management of postoperative pain. Unlike IT administration of LA, IT opioids produce 'segmental' analgesia and are not associated with muscle weakness, loss of proprioception or sympathetic block. IT opioids can be administered as an adjunct to general anaesthesia or combined with LA and administered during spinal anaesthesia for surgery. It is one of the easiest, most reliable and cost-effective methods for pain relief. Intrathecal opioid administration can provide more intense analgesia than the IV route and has the advantages of simplicity and reliability.
- Conditions
- Postoperative Pain, Pediatric Open Heart Surgery
- Being tested
- PIFB group, Intrathecal fentanyl(IT fentanyl), IT + PIFB
- Keywords
- Intercostal Fascial Block, intrathecal fentanyl, Paediatric Cardiac Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIFB groupProcedure or surgery
A pecto-intercostal-fascial plane block (PIFB) will be performed bilaterally in a supine position after induction of anaesthesia. The in-plane needle approach will be applied under the guidance of a high-frequency Hockey Stick Linear-Array US transducer probe (SONOSITE M-TURBO). Under strict aseptic precautions, the transducer will be placed 1-2 cm lateral to and parallel to the sternum to count the ribs from the second to the sixth rib. A 22-gauge, 50-mm short bevel echogenic needle will be advanced in a caudal-to-cranial direction until the tip of the needle will be in the targeted fascial plane, a test bolus of normal saline (1-2 mL) will be injected (in real-time) to confirm that the tip was correctly placed, as shown by separation of the fascial layers. After excluding intravascular, the dose of local anaesthetic (0.4 mL/kg 0.25% bupivacaine) will be deposited into the fascial plane visualised in real-time.
Intrathecal fentanyl(IT fentanyl)Procedure or surgery
IT fentanyl group (Group IT; n = 30) will be placed in lateral decubitus position immediately after intubation and catheterisation and receive an IT injection of 2 µg/kg of fentanyl in 0.2 mL/kg of normal saline through a 2-in., 25-gauge Quincke spinal needle inserted at L3-4 or L4-5. The dose of IT fentanyl will be based on a previous study. (15) with this route of fentanyl administration to provide intraoperative analgesia and blunt the stress response in pediatric cardiac anaesthesia. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid, and the injection will be performed with the bevel of the needle oriented in the cephalic direction.
IT + PIFBProcedure or surgery
Patients assigned to the combined IT fentanyl and PIFB (Group IT + PIFB; n = 30) will receive both a PIFB and IT fentanyl, with the use of the methods described for the other two groups.
| Study group | Role | What they receive |
|---|---|---|
| Pecto-Intercostal Fascial Block group | Experimental | The PIFB group (Group PIFB; n = 30) will receive a pecto-intercostal-fascial plane block (PIFB). The blocks will be performed bilaterally in a supine position after induction of anaesthesia. The in-plane needle approach will be applied under the guidance of a high-frequency Hockey Stick Linear-Array US transducer probe (SONOSITE M-TURBO). Under strict aseptic precautions, the transducer will be placed 1-2 cm lateral to and parallel to the sternum to count the ribs from the second to the sixth rib. A 22-gauge, 50-mm short bevel echogenic needle will be advanced in a caudal-to-cranial direction until the tip of the needle will be in the targeted fascial plane, a test bolus of normal saline (1-2 mL) will be injected (in real-time) to confirm that the tip was correctly placed, as shown by separation of the fascial layers. After excluding intravascular, the dose of local anaesthetic (0.4 mL/kg 0.25% bupivacaine) will be deposited into the fascial plane visualised in real-time. Receives: Procedure: PIFB group |
| Intrathecal fentanyl group | Active comparator | The children in the IT fentanyl group (Group IT; n = 30) will be placed in lateral decubitus position immediately after intubation and catheterisation and receive an IT injection of 2 µg/kg of fentanyl in 0.2 mL/kg of normal saline through a 2-in., 25-gauge Quincke spinal needle inserted at L3-4 or L4-5. The dose of IT fentanyl will be based on a previous study. (15) with this route of fentanyl administration to provide intraoperative analgesia and blunt the stress response in pediatric cardiac anaesthesia. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid, and the injection will be performed with the bevel of the needle oriented in the cephalic direction. Receives: Procedure: Intrathecal fentanyl(IT fentanyl) |
| intrathecal fentanyl and pectointercostal fascial block | Active comparator | Patients assigned to the combined IT fentanyl and PIFB (Group IT + PIFB; n = 30) will receive both a PIFB and IT fentanyl, with the use of the methods described for the other two groups. Receives: Procedure: IT + PIFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate how effectively three distinct pain management techniques can reduce the stress response that patients experience after undergoing cardiac surgery.
Serum cortisol and plasma epinephrine and norepinephrine will be measured.
Measured: after the procedure24 hour
Secondary outcomes (5)
To conduct a comparative analysis of the analgesic efficacy of each pain management method.
-Analgesia/sedation scores will be recorded The team will evaluate each child for the level of analgesia and sedation using the COMFORT scale. (16) (before extubation) and the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (17) (after extubation)
Measured: every 30 minutes for the first six postoperative hours and every 6 hours during the first, second, and third postoperative days.
To meticulously document and evaluate any potential adverse effects associated with these pain management strategies, ensuring patient safety.
The incidence of adverse events associated with the block is as follows: local anaesthesia toxicity (neurologic or cardiovascular events occurring within the first 30 min after block administration), chest wall hematoma, and pneumothorax (diagnosed by the US after block and before skin incision).
Measured: first 30 min after block administration and 24 hour postoperatively
to determine which technique offers the most effective in early extubation
The time to extubate (in minutes )
Measured: in first 24 hour postoperatively
to determine the duration of analgesic effect of technique post operative
The time for first rescue analgesia in minutes
Measured: in first 24 hour postoperatively
to determine which technique offers lesser consumption of fentanyl
The total dose of fentanyl consumed intraoperatively and for each of the first 3 days postoperatively (µg/kg).
Measured: intraoperative during the procedure and first 3 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start20 Apr 2025 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Islam Elbardan, Dr, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882655
- Sponsor's protocol ID
- IRB NO : 00012098
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Intrathecal Fentanyl and Ultrasound-Guided Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06882655
- Acronym / sponsor ID
- IRB NO : 00012098
- Conditions
- Postoperative Pain, Pediatric Open Heart Surgery
- Keywords
- Intercostal Fascial Block, intrathecal fentanyl, Paediatric Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 18 Mar 2025 (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 surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Recently, thoracic myofascial plane blocks with ultrasound guidance as part of multimodal analgesia have contributed to a faster recovery after surgery.
De la Torre et al. first described pectointercostal fascial plane block (PIFPB) for breast surgery. Local anaesthetics are injected between the pectoralis major and internal intercostal muscles close to the sternum to block the anterior cutaneous branch of the second-to-sixth thoracic intercostal nerves.The use of intrathecal (IT) opioids with or without local anaesthetics (LA) is a popular analgesic technique around the world for the management of postoperative pain. Unlike IT administration of LA, IT opioids produce 'segmental' analgesia and are not associated with muscle weakness, loss of proprioception or sympathetic block. IT opioids can be administered as an adjunct to general anaesthesia or combined with LA and administered during spinal anaesthesia for surgery. It is one of the easiest, most reliable and cost-effective methods for pain relief. Intrathecal opioid administration can provide more intense analgesia than the IV route and has the advantages of simplicity and reliability
Detailed description
Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Sternal wound pain has been linked to diminished patient satisfaction, delirium, and a spectrum of cardiovascular complications, including hypotension, tachycardia, arrhythmias, and respiratory issues such as stasis of bronchial secretions, atelectasis, and pneumonia.
Pain management after cardiac surgery is critical to enhancing recovery. Various modalities are available for managing postoperative pain in cardiac surgery. These modalities include opioids, local anaesthetic techniques such as local anaesthetic infiltration, and neuraxial blocks (epidural and paravertebral). Additionally, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are feasible options for pain control. Furthermore, adjunct analgesics such as steroids, ketamine, α2 agonists, and anticonvulsants are also employed for effective pain management.Opioids can elicit various adverse effects, such as delayed tracheal extubation, respiratory depression, sedation, ileus, nausea, vomiting, immunosuppression, cough suppression, drowsiness, and an increased risk of chronic pain.
Recently, thoracic myofascial plane blocks with ultrasound guidance as part of multimodal analgesia have contributed to a faster recovery after surgery.
De la Torre et al.first described pectointercostal fascial plane block (PIFPB) for breast surgery. Local anaesthetics are injected between the pectoralis major and internal intercostal muscles close to the sternum to block the anterior cutaneous branch of the second-to-sixth thoracic intercostal nerves. PIFPB has been an effective technique for pain control after sternotomy . However, a high incidence of non-sternal wound pain was observed with this technique of fascial plain block both in adults and paediatrics after cardiac surgery .
The use of intrathecal (IT) opioids with or without local anaesthetics (LA) is a popular analgesic technique around the world for the management of postoperative pain. Unlike IT administration of LA, IT opioids produce 'segmental' analgesia and are not associated with muscle weakness, loss of proprioception or sympathetic block. IT opioids can be administered as an adjunct to general anaesthesia or combined with LA and administered during spinal anaesthesia for surgery. It is one of the easiest, most reliable and cost-effective methods for pain relief. Intrathecal opioid administration can provide more intense analgesia than the IV route and has the advantages of simplicity and reliability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pecto-Intercostal Fascial Block group | Experimental | Procedure: PIFB groupThe PIFB group (Group PIFB; n = 30) will receive a pecto-intercostal-fascial plane block (PIFB). The blocks will be performed bilaterally in a supine position after induction of anaesthesia. The in-plane needle approach will be applied under the guidance of a high-frequency Hockey Stick Linear-Array US transducer probe (SONOSITE M-TURBO). Under strict aseptic precautions, the transducer will be placed 1-2 cm lateral to and parallel to the sternum to count the ribs from the second to the sixth rib. A 22-gauge, 50-mm short bevel echogenic needle will be advanced in a caudal-to-cranial direction until the tip of the needle will be in the targeted fascial plane, a test bolus of normal saline (1-2 mL) will be injected (in real-time) to confirm that the tip was correctly placed, as shown by separation of the fascial layers. After excluding intravascular, the dose of local anaesthetic (0.4 mL/kg 0.25% bupivacaine) will be deposited into the fascial plane visualised in real-time. |
| Intrathecal fentanyl group | Active comparator | Procedure: Intrathecal fentanyl(IT fentanyl)The children in the IT fentanyl group (Group IT; n = 30) will be placed in lateral decubitus position immediately after intubation and catheterisation and receive an IT injection of 2 µg/kg of fentanyl in 0.2 mL/kg of normal saline through a 2-in., 25-gauge Quincke spinal needle inserted at L3-4 or L4-5. The dose of IT fentanyl will be based on a previous study. (15) with this route of fentanyl administration to provide intraoperative analgesia and blunt the stress response in pediatric cardiac anaesthesia. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid, and the injection will be performed with the bevel of the needle oriented in the cephalic direction. |
| intrathecal fentanyl and pectointercostal fascial block | Active comparator | Procedure: IT + PIFBPatients assigned to the combined IT fentanyl and PIFB (Group IT + PIFB; n = 30) will receive both a PIFB and IT fentanyl, with the use of the methods described for the other two groups. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The enrolled patients ranged in age from 6 months to 6 years,
- patients scheduled for surgical repair of congenital heart defects.
Key exclusion criteria (3 listed)
- The preoperative criteria include a history of previous cardiac surgery, hemodynamic instability, the need for mechanical ventilation, and the requirement for vasoactive drugs, opioids, or corticosteroids.
- During the intraoperative phase, who use of deep hypothermic circulatory arrest and the necessity for vasoactive drugs, excluding the temporary use of dopamine and dobutamine at a maximum dose of 10 µg/kg/min.
- Postoperative exclusion conditions will include prolonged mechanical ventilation lasting more than 24 hours, hemodynamic instability, and the need for high doses of opioids or sedatives.
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 |
|---|---|---|
| PIFB groupA pecto-intercostal-fascial plane block (PIFB) will be performed bilaterally in a supine position after induction of anaesthesia. The in-plane needle approach will be applied under the guidance of a high-frequency Hockey Stick Linear-Array US transducer probe (SONOSITE M-TURBO). Under strict aseptic precautions, the transducer will be placed 1-2 cm lateral to and parallel to the sternum to count the ribs from the second to the sixth rib. A 22-gauge, 50-mm short bevel echogenic needle will be advanced in a caudal-to-cranial direction until the tip of the needle will be in the targeted fascial plane, a test bolus of normal saline (1-2 mL) will be injected (in real-time) to confirm that the tip was correctly placed, as shown by separation of the fascial layers. After excluding intravascular, the dose of local anaesthetic (0.4 mL/kg 0.25% bupivacaine) will be deposited into the fascial plane visualised in real-time. | Procedure or surgery | Pecto-Intercostal Fascial Block group |
| Intrathecal fentanyl(IT fentanyl)IT fentanyl group (Group IT; n = 30) will be placed in lateral decubitus position immediately after intubation and catheterisation and receive an IT injection of 2 µg/kg of fentanyl in 0.2 mL/kg of normal saline through a 2-in., 25-gauge Quincke spinal needle inserted at L3-4 or L4-5. The dose of IT fentanyl will be based on a previous study. (15) with this route of fentanyl administration to provide intraoperative analgesia and blunt the stress response in pediatric cardiac anaesthesia. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid, and the injection will be performed with the bevel of the needle oriented in the cephalic direction. | Procedure or surgery | Intrathecal fentanyl group |
| IT + PIFBPatients assigned to the combined IT fentanyl and PIFB (Group IT + PIFB; n = 30) will receive both a PIFB and IT fentanyl, with the use of the methods described for the other two groups. | Procedure or surgery | intrathecal fentanyl and pectointercostal fascial block |
Primary outcome
To investigate how effectively three distinct pain management techniques can reduce the stress response that patients experience after undergoing cardiac surgery.
Time frame: after the procedure24 hour
Serum cortisol and plasma epinephrine and norepinephrine will be measured.
5 secondary outcomes
To conduct a comparative analysis of the analgesic efficacy of each pain management method.
Time frame: every 30 minutes for the first six postoperative hours and every 6 hours during the first, second, and third postoperative days.
To meticulously document and evaluate any potential adverse effects associated with these pain management strategies, ensuring patient safety.
Time frame: first 30 min after block administration and 24 hour postoperatively
to determine which technique offers the most effective in early extubation
Time frame: in first 24 hour postoperatively
to determine the duration of analgesic effect of technique post operative
Time frame: in first 24 hour postoperatively
to determine which technique offers lesser consumption of fentanyl
Time frame: intraoperative during the procedure and first 3 days post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- 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.
Islam Elbardan, Dr principal investigator
University of Alexandria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIFB group, Intrathecal fentanyl(IT fentanyl) and IT + PIFB in people with Postoperative Pain and Pediatric Open Heart Surgery, run by Alexandria University at 2 sites 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hesham ELgoweini, Prof.Dr (00201287740750, ethics.comm@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate how effectively three distinct pain management techniques can reduce the stress response that patients experience after undergoing cardiac surgery. (time frame: after the procedure24 hour). 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 15 Apr 2025.