PainNCT05627869
Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
A study testing Transversus thoracic plane block and Pecto intercostal fascial block in people with Pain and Postoperative, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Transversus thoracic plane block and Pecto intercostal fascial block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to Jul 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
- American Society of Anesthesiologists classification of physical status < IV.
Who cannot join
- Emergency surgery.
- Off-pump surgery.
- Redo surgery.
- Ejection fraction less than 35%.
- Refusal of the patient.
- Known hypersensitivity to LA.
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- Chronic opioid use or chronic pain patient.
- Psychiatric problems or communication difficulties.
- Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)
- Renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
- Obstructive sleep apnea syndrome.
- Coexisting hematologic disorders.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benisuef University Hospital
Benisuef
مريانة عبد السيد سليمان, MD, 01222960009, mrmrsyk4@gmail.com
About this study
Official title: Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study
The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.
Read the detailed description
Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.
- Conditions
- Pain, Postoperative
- Being tested
- Transversus thoracic plane block, Pecto intercostal fascial block
- Keywords
- TTPB, PIFB
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus thoracic plane blockProcedure or surgery
Also called sunnypivacaine
TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.
Pecto intercostal fascial blockProcedure or surgery
Also called sunnypivacaine
PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.
| Study group | Role | What they receive |
|---|---|---|
| Transversus thoracic muscle plane block | Active comparator | TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side. Receives: Procedure: Transversus thoracic plane block |
| Pecto-intercostal fascial plane block | Active comparator | PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side. Receives: Procedure: Pecto intercostal fascial block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be total morphine consumption
Total morphine consumption within 24 hours according Visual Analogue Score (VAS) for sternal pain both during rest and with cough (ranging from 0 indicating no pain to 10 indicating extreme pain). A score ≤ 3 was considered acceptable for pain relief. Supplementary rescue analgesia was administered in the form of morphine IV 0.05 mg/kg (at VAS ≥ 4).
Measured: 24 hours
Secondary outcomes (1)
The secondary outcomes will be the first analgesic request time
Is the time to ask for the first postoperative analgesia (morphine), and will be calculated from extubation to patient reporting Visual Analogue Score (VAS) ≥ 4.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Feb 2023
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Soliman, Beni-Suef University
- Investigators
- Mariana A Mansour, Lecturer, Principal investigator, Benisuef university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627869
- Sponsor's protocol ID
- Mariana AbdElsayed
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: TITLE
Publications
Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.
PubMed 38341525
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05627869
- Acronym / sponsor ID
- Mariana AbdElsayed
- Conditions
- Pain, Postoperative
- Keywords
- TTPB, PIFB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 28 Nov 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 objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.
Detailed description
Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus thoracic muscle plane block | Active comparator | Procedure: Transversus thoracic plane blockTTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side. |
| Pecto-intercostal fascial plane block | Active comparator | Procedure: Pecto intercostal fascial blockPIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years.
- Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
- American Society of Anesthesiologists classification of physical status < IV.
Key exclusion criteria (13 listed)
- Emergency surgery.
- Off-pump surgery.
- Redo surgery.
- Ejection fraction less than 35%.
- Refusal of the patient.
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 |
|---|---|---|
| Transversus thoracic plane blockAlso: sunnypivacaineTTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side. | Procedure or surgery | Transversus thoracic muscle plane block |
| Pecto intercostal fascial blockAlso: sunnypivacainePIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side. | Procedure or surgery | Pecto-intercostal fascial plane block |
Primary outcome
The primary outcome will be total morphine consumption
Time frame: 24 hours
Total morphine consumption within 24 hours according Visual Analogue Score (VAS) for sternal pain both during rest and with cough (ranging from 0 indicating no pain to 10 indicating extreme pain). A score ≤ 3 was considered acceptable for pain relief. Supplementary rescue analgesia was administered in the form of morphine IV 0.05 mg/kg (at VAS ≥ 4).
1 secondary outcome
The secondary outcomes will be the first analgesic request time
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 38341525Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.
- Individual participant dataSharing planned: No. TITLE
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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.
Mariana A Mansour, Lecturer principal investigator
Benisuef university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus thoracic plane block and Pecto intercostal fascial block in people with Pain and Postoperative, run by Beni-Suef 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 11 Jul 2023. 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 Mariana A Mansour, lecturer (01222960009, mrmrsyk4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be total morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05627869, which also lists 1 linked publication.
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 11 Jul 2023.