Pain, Post OperativeNCT05323305
Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients
A study testing ultrasound guided regional block in people with Pain, Post Operative, run by Alexandria University at 1 site in Egypt.
Trial summary
The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Post Operative
- What is being tested?
- ultrasound guided regional block
- 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
- 30 Mar 2022to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient.
- Elective cardiac surgery.
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.
- when extubation is intentionally planned to be delayed
Trial locations and contacts
1 site in 1 country.
Ibrahim Ibrahim, MD contact
About this study
Official title: Ultrasound Guided Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients: A Comparative Study
The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.
Read the detailed description
A prospective study will be carried out in Alexandria Main University Hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the Ethical Committee of Faculty of Medicine, Alexandria, and having an informed written consent taken from patients included in the study. Patients will be categorized into two equal groups; group P (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group T (n=30) will receive ultrasound-guided transversus thoracic plane block.
All patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the ICU. Patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.
- Conditions
- Pain, Post Operative
- Being tested
- ultrasound guided regional block
- Keywords
- Ultrasound, pectointercostal, 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.
ultrasound guided regional blockProcedure or surgery
Also called ultrasound guided nerve block
Bupivacaine injection by the use of ultrasound in the pectointercostal fascial plane in one group and in the trasversus thoracic plane in the other group.
| Study group | Role | What they receive |
|---|---|---|
| Pectointercostal Group (n=30) | Active comparator | They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care. Receives: Procedure: ultrasound guided regional block |
| Transversus thoracic Group (n=30) | Active comparator | They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care. Receives: Procedure: ultrasound guided regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the analgesic effectiveness of the two blocks on midline sternotomy pain,
Postoperative pain evaluation after extubation will be done using the Visual Analogue Scale (VAS). a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."
Measured: from end of surgery till discharge from ICU (96 hours)
Secondary outcomes (2)
pulmonary complications
atelectasis and pneumonia
Measured: from end of surgery till discharge from ICU (96 hours)
length of stay in ICU
days from admission till discharge from ICU
Measured: average 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start30 Mar 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post OperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- islam Omar, MD, Study chair, Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria universityIbrahim Ibrahim, MD, Principal investigator, Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria universityMoustafa Halwag, MD, Study director, Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323305
- Sponsor's protocol ID
- 0305468
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients: A Comparative Study
- ClinicalTrials.gov ID
- NCT05323305
- Acronym / sponsor ID
- 0305468
- Conditions
- Pain, Post Operative
- Keywords
- Ultrasound, pectointercostal, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Apr 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 study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.
Detailed description
A prospective study will be carried out in Alexandria Main University Hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the Ethical Committee of Faculty of Medicine, Alexandria, and having an informed written consent taken from patients included in the study. Patients will be categorized into two equal groups; group P (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group T (n=30) will receive ultrasound-guided transversus thoracic plane block.
All patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the ICU. Patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectointercostal Group (n=30) | Active comparator | Procedure: ultrasound guided regional blockThey will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care. |
| Transversus thoracic Group (n=30) | Active comparator | Procedure: ultrasound guided regional blockThey will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient.
- Elective cardiac surgery.
Key exclusion criteria (7 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.
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 regional blockAlso: ultrasound guided nerve blockBupivacaine injection by the use of ultrasound in the pectointercostal fascial plane in one group and in the trasversus thoracic plane in the other group. | Procedure or surgery | Pectointercostal Group (n=30), Transversus thoracic Group (n=30) |
Primary outcome
the analgesic effectiveness of the two blocks on midline sternotomy pain,
Time frame: from end of surgery till discharge from ICU (96 hours)
Postoperative pain evaluation after extubation will be done using the Visual Analogue Scale (VAS). a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."
2 secondary outcomes
pulmonary complications
Time frame: from end of surgery till discharge from ICU (96 hours)
length of stay in ICU
Time frame: average 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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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.
Ibrahim Ibrahim, MD contact
islam Omar, MD study chair
Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
Ibrahim Ibrahim, MD principal investigator
Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
Moustafa Halwag, MD study director
Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
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 regional block in people with Pain, Post Operative, 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 2 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: status not confirmed, as of the sponsor's last update on 12 Apr 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.
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 Islam Omar, MD (+201227851759, i_omar12@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the analgesic effectiveness of the two blocks on midline sternotomy pain, (time frame: from end of surgery till discharge from ICU (96 hours)). 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 12 Apr 2022.