Local InfiltrationNCT04918433
Comparison of Two Regional Anaesthetic Blocks for ERAS After Congenital Cardiac Surgery
A study testing Regional anaesthesia in people with Local Infiltration, run by University of Alexandria at 1 site in Egypt.
Trial summary
The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Local Infiltration
- What is being tested?
- Regional anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 25 Jul 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
- either sex, aged 2-12 years, undergoing
- elective cardiac surgery via median sternotomy
Who cannot join
- refusal to participate, redo or 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, 23541
Nagwa Kobea, Phd, +20 122 336 8233, kobea@yahoo.com
About this study
Official title: Comparison of Pectointercostal Block and Transverse Thoracic Plane Block for ERAS Post Congenital Cardiac Surgery
The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy
Read the detailed description
Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or 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, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.
- Conditions
- Local Infiltration
- Being tested
- Regional anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anaesthesiaProcedure or surgery
Regional anaesthesia for sternotomy incision for congenital cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB) | Active comparator | After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine Receives: Procedure: Regional anaesthesia |
| PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB) | Active comparator | After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine Receives: Procedure: Regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight, height , BMI
Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)
Measured: 1 year
Postoperative pain score
Postoperative pain score at rest, hemodynamic effects, analgesic consumption
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Jun 2021
- Primary completion25 Jun 2022 (estimated)
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local InfiltrationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mabrouk Ibrahim, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918433
- Sponsor's protocol ID
- 118
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pectointercostal Block and Transverse Thoracic Plane Block for ERAS Post Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04918433
- Acronym / sponsor ID
- 118
- Conditions
- Local Infiltration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 8 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.
The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy
Detailed description
Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or 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, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB) | Active comparator | Procedure: Regional anaesthesiaAfter induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine |
| PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB) | Active comparator | Procedure: Regional anaesthesiaAfter induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- either sex, aged 2-12 years, undergoing
- elective cardiac surgery via median sternotomy
Key exclusion criteria (1 listed)
- refusal to participate, redo or 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
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 |
|---|---|---|
| Regional anaesthesiaRegional anaesthesia for sternotomy incision for congenital cardiac surgery | Procedure or surgery | PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB), TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB) |
Primary outcome
Weight, height , BMI
Time frame: 1 year
Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)
Postoperative pain score
Time frame: 1 year
Postoperative pain score at rest, hemodynamic effects, analgesic consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anaesthesia in people with Local Infiltration, run by University of Alexandria 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 2 inclusion and 1 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 8 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. 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 Ibrahim Mabrouk, Phd (00201224336786, ibrahim_wama@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight, height , BMI (time frame: 1 year). 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 8 Jun 2021.