Cardiac Septal Defects With Coarctation of the AortaPhase 2NCT05475561
Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
A Phase 2 study testing Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block and Bupivacain in people with Cardiac Septal Defects With Coarctation of the Aorta and Mitral Regurgitation, run by Alexandria University at 1 site in Egypt.
Trial summary
The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cardiac Septal Defects With Coarctation of the Aorta, Mitral Regurgitation
- What is being tested?
- Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block and Bupivacain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2022to 5 Jul 2022
- Phase
- Phase 2
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients of either sex
- aged 18-50 years
- undergoing elective cardiac surgery via median sternotomy
Who cannot join
- refusal to participate,
- redo
- urgent cardiac surgery
- local infection of the skin at the site of needle puncture
- allergy to bupivacaine, coagulation disorders
- clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension
- extubation is intentionally planned to be delayed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spinae Plane Block and Pecto-Intercostal Facial Plane Block For Enhanced Recovery After Sternotomy in Adult Cardiac Surgery
The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy.
The primary outcome measure will be the analgesic effectiveness of both blocks in median sternotomy pain, while the secondary outcome measures will be time to extubation, and length of intensive care unit stay.
Read the detailed description
The patients will undergo the same preoperative preparation, intraoperative monitoring, and anesthetic technique. Fentanyl (2 μg/kg) will be given with induction of anesthesia, and additional increments of fentanyl 2 μg/kg will be administered if mean arterial blood pressure or heart rate rise in response to stressful surgical stimuli greater than 20% above baseline.
All surgeries will be performed through median sternotomy, with the same cardiopulmonary bypass and myocardial protection technique. At the end of surgery, all anesthetics will be discontinued, and patients will be transferred to the ICU where they will be committed to a mechanical ventilator.
the two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.
he two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.
Ultrasound guided Pecto-intercostal- fascial plane block:
The block will be performed while the patient in supine position after induction of general anesthesia and before skin incision. The probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected. As the drug will be injected, a hydro dissection of the plane is checked for. At this point, color doppler ultrasonography will be used to help identify the internal thoracic artery and its branches that pass through the plan.
Ultrasound guided erector spinae plane block:
The block will be done while the patient is in the sitting position before induction of general anesthesia. A high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process. Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.
- Being tested
- Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block, Bupivacain
- Medical subject headings
- Cardiac Septal Defects with Coarctation of the Aorta, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Pecto-intercostal- fascial plane blockProcedure or surgery
The probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected.
Ultrasound guided erector spinae plane blockProcedure or surgery
A high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.
BupivacainDrug
local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Group (P) | Active comparator | Not described Receives: Procedure: Ultrasound guided Pecto-intercostal- fascial plane block; Drug: Bupivacain |
| Group (E) | Active comparator | Not described Receives: Procedure: Ultrasound guided erector spinae plane block; Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of fentanyl consumption
Analgesic effectiveness of both blocks in median sternotomy pain
Measured: after 1 hour postoperative
Total dose of fentanyl consumption
Analgesic effectiveness of both blocks in median sternotomy pain
Measured: after 24 hours postoperative
Secondary outcomes (2)
time to extubation
the time from ICU arrival till endotracheal extubation.
Measured: after 1 hour of removal of endotracheal tube
ICU Length of stay
length of intensive care unit stay.
Measured: after 48 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start25 May 2022
- Primary completion30 Jun 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Septal Defects With Coarctation of the AortaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475561
- Sponsor's protocol ID
- 0305600
- Status last verified
- May 2022
- First submitted
- 7 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block and Pecto-Intercostal Facial Plane Block For Enhanced Recovery After Sternotomy in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05475561
- Acronym / sponsor ID
- 0305600
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 27 Jul 2022 (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.
The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy.
The primary outcome measure will be the analgesic effectiveness of both blocks in median sternotomy pain, while the secondary outcome measures will be time to extubation, and length of intensive care unit stay.
Detailed description
The patients will undergo the same preoperative preparation, intraoperative monitoring, and anesthetic technique. Fentanyl (2 μg/kg) will be given with induction of anesthesia, and additional increments of fentanyl 2 μg/kg will be administered if mean arterial blood pressure or heart rate rise in response to stressful surgical stimuli greater than 20% above baseline.
All surgeries will be performed through median sternotomy, with the same cardiopulmonary bypass and myocardial protection technique. At the end of surgery, all anesthetics will be discontinued, and patients will be transferred to the ICU where they will be committed to a mechanical ventilator.
the two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.
he two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.
Ultrasound guided Pecto-intercostal- fascial plane block:
The block will be performed while the patient in supine position after induction of general anesthesia and before skin incision. The probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected. As the drug will be injected, a hydro dissection of the plane is checked for. At this point, color doppler ultrasonography will be used to help identify the internal thoracic artery and its branches that pass through the plan.
Ultrasound guided erector spinae plane block:
The block will be done while the patient is in the sitting position before induction of general anesthesia. A high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process. Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (P) | Active comparator | Procedure: Ultrasound guided Pecto-intercostal- fascial plane block, Drug: Bupivacain |
| Group (E) | Active comparator | Procedure: Ultrasound guided erector spinae plane block, Drug: Bupivacain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adult patients of either sex
- aged 18-50 years
- undergoing elective cardiac surgery via median sternotomy
Key exclusion criteria (7 listed)
- refusal to participate,
- redo
- urgent cardiac surgery
- local infection of the skin at the site of needle puncture
- allergy to bupivacaine, coagulation disorders
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 Pecto-intercostal- fascial plane blockThe probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected. | Procedure or surgery | Group (P) |
| Ultrasound guided erector spinae plane blockA high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side. | Procedure or surgery | Group (E) |
| Bupivacainlocal anesthetic | Drug | Group (E), Group (P) |
Primary outcome
Total dose of fentanyl consumption
Time frame: after 1 hour postoperative
Analgesic effectiveness of both blocks in median sternotomy pain
Total dose of fentanyl consumption
Time frame: after 24 hours postoperative
Analgesic effectiveness of both blocks in median sternotomy pain
2 secondary outcomes
time to extubation
Time frame: after 1 hour of removal of endotracheal tube
ICU Length of stay
Time frame: after 48 hour 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 27 Jul 2022.
Related trials for Cardiac Septal Defects With Coarctation of the Aorta
RecruitingObservational study
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Congenital Heart Defect, Single-ventricle
RecruitingObservational study
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
Congenital Heart Disease, Coarctation of Aorta
Not yet recruitingObservational study
Canadian Adult Congenital Heart Disease Intervention Registry
Atrial Septal Defect, Patent Foramen Ovale
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 2 study testing Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block and Bupivacain in people with Cardiac Septal Defects With Coarctation of the Aorta and Mitral Regurgitation, run by Alexandria 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 7 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 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total dose of fentanyl consumption (time frame: after 1 hour postoperative). 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 27 Jul 2022.