Coronary Artery DiseaseNCT06418100
Recto-intercostal Block for Coronary Artery Bypass Grafting
A study testing The recto intercostal fascial plane block in people with Coronary Artery Disease and Peripheral Nerve Blocks, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block, recto-intercostal fascial plane block, at coronary artery bypass grafting with sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Peripheral Nerve Blocks, Sternotomy
- What is being tested?
- The recto intercostal fascial plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will undergo CABG surgery with sternotomy
- patients who have an American Society of Anesthesiologists (ASA) Physical Status classification of III to IV
Who cannot join
- refusal to participate
- a history of neurological deficits or neuropathy affecting the thoracal innervation
- infection at the site of block application
- allergy to local anesthetics
- epilepsy or treatment with antipsychotics
- abuse of alcohol or drugs
- previous surgery distorting the anatomy of the sternum, thorax or upper abdominal area
- severe organ dysfunction ( kidney, liver and other); patients who fail at weaning after 12 hours of surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi
About this study
Official title: Recto-intercostal Fascial Plane Block for Postoperative Analgesia in Coronary Artery Bypass Grafting With Sternotomy: a Randomized, Double-blind, Controlled Study
This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block, recto-intercostal fascial plane block, at coronary artery bypass grafting with sternotomy. There will be two groups, one of which will be the control group, and the other will be the study group randomly receiving postoperative recto-intercostal fascial plane block.
The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores. Also, postoperative outcomes related to respiratory ( postoperative oxygenation and atelectasis score), hemodynamic functions ( newly developed arrhythmias), total postanesthesia care unit stay, and hospital stay will be questioned.
Read the detailed description
All patients will receive standard general anaesthesia under standard monitoring along with the bispectral index (Medtronic). Intubation will be performed by administering intravenous (IV) 0,03 mg/kg midazolam, propofol (Lipuro, Braun, max. 2 mg/kg according to BIS), two mcg/kg fentanyl (Talinat, VEM), 1 mg /kg rocuronium (Esmeron, Alessandroorsini) followed by 1 MAC sevoflurane (Sevorane, Abbott) in an air-oxygen mixture for maintenance of anaesthesia. Following anaesthesia induction, all participants will receive superficial parasternal intercostal plane block (SPIP) bilaterally along with 8 mg dexamethasone before surgical incision as part of multimodal analgesia by a single experienced regional anaesthesiologist (B.C.) under ultrasound guidance (Esaote MyLab ™ Seven). SPIPB will be performed using a high-frequency probe to visualize the pectointercostal fascial area at the intercostal level of the intercostal 3-4 level, and 20 ml %0,25 bupivacaine was injected bilaterally. After applying SPIPB, the surgery is set to begin after at least 15 minutes of block procedure. The intraoperative analgesic need will be supplied by fentanyl bolus doses as 50 mcq if necessary, as heart rate or systolic blood pressure increases by more than %15. According to randomization, the intervention group will receive RIFPB with 10 ml %0,25 bupivacaine.
From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS is over four or with the patient's request. The routine analgesia regimen was 1 gram IV paracetamol 6th hourly postoperatively at the PACU. All patients were followed up from the extubation time till hospital discharge to evaluate respiratory and hemodynamic changes, possible complications and total postoperative time.
- Conditions
- Coronary Artery Disease, Peripheral Nerve Blocks, Sternotomy
- Being tested
- The recto intercostal fascial plane block
- Keywords
- coronary artery bypass grafting, Parasternal intercostal plane block, Recto-intercostal fascial plane block, Postoperative analgesia
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The recto intercostal fascial plane blockProcedure or surgery
After ensuring aseptic conditions, the high-frequency linear ultrasound probe was used to detect the rectus abdominis muscle and the 6-7th costal cartilage as described by Tulgar et al. After rotating and shifting the transducer, 6-7th costal cartilages, the rectus abdominis muscle, and intercostal muscles between the cartilages were confirmed. The primary investigator (B.C.) directed the needle tip caudad in the cephalic direction in-plainly, and 20 ml 0,25% bupivacaine was injected bilaterally into the plane between the costal cartilage and the rectus abdominis muscle following negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| The Control | No intervention | The participants will have standardized anaesthesia management and receive postoperative rescue analgesia as morphine. |
| The rectointercostal fascial plane block | Experimental | The participants will receive postoperative recto intercostal fascial plane block, with 20 ml 0,25 bupivacaine bilaterally. Receives: Procedure: The recto intercostal fascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total rescue analgesic
. From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS over 4 or with the patient's request.
Measured: postoperative 24 hour
Secondary outcomes (4)
intraoperative opioid use
total amount of opioid use as fentanyl intraoperatively
Measured: intraoperative
intraoperative hemodynamic change
systolic blood pressure
Measured: at sternotomy
postoperative respiratory function
postoperative atelectasis score
Measured: postoperative 48 hour
postoperative arythmias
postoperative arythmias especially atrial fibrillation
Measured: postoperative 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Mar 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, triple-blind, controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, Principal investigator, Haseki Training and Research Hospital Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418100
- Sponsor's protocol ID
- 272-2023
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
PubMed 37295124Chen Y, Li Q, Liao Y, Wang X, Zhan MY, Li YY, Liu GJ, Xiao L. Preemptive deep parasternal intercostal plane block for perioperative analgesia in coronary artery bypass grafting with sternotomy: a randomized, observer-blind, controlled study. Ann Med. 2023;55(2):2302983. doi: 10.1080/07853890.2024.2302983. Epub 2024 Feb 20.
PubMed 38375661
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recto-intercostal Fascial Plane Block for Postoperative Analgesia in Coronary Artery Bypass Grafting With Sternotomy: a Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT06418100
- Acronym / sponsor ID
- 272-2023
- Conditions
- Coronary Artery Disease, Peripheral Nerve Blocks, Sternotomy
- Keywords
- coronary artery bypass grafting, Parasternal intercostal plane block, Recto-intercostal fascial plane block, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 May 2024 (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.
This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block, recto-intercostal fascial plane block, at coronary artery bypass grafting with sternotomy. There will be two groups, one of which will be the control group, and the other will be the study group randomly receiving postoperative recto-intercostal fascial plane block.
The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores. Also, postoperative outcomes related to respiratory ( postoperative oxygenation and atelectasis score), hemodynamic functions ( newly developed arrhythmias), total postanesthesia care unit stay, and hospital stay will be questioned.
Detailed description
All patients will receive standard general anaesthesia under standard monitoring along with the bispectral index (Medtronic). Intubation will be performed by administering intravenous (IV) 0,03 mg/kg midazolam, propofol (Lipuro, Braun, max. 2 mg/kg according to BIS), two mcg/kg fentanyl (Talinat, VEM), 1 mg /kg rocuronium (Esmeron, Alessandroorsini) followed by 1 MAC sevoflurane (Sevorane, Abbott) in an air-oxygen mixture for maintenance of anaesthesia. Following anaesthesia induction, all participants will receive superficial parasternal intercostal plane block (SPIP) bilaterally along with 8 mg dexamethasone before surgical incision as part of multimodal analgesia by a single experienced regional anaesthesiologist (B.C.) under ultrasound guidance (Esaote MyLab ™ Seven). SPIPB will be performed using a high-frequency probe to visualize the pectointercostal fascial area at the intercostal level of the intercostal 3-4 level, and 20 ml %0,25 bupivacaine was injected bilaterally. After applying SPIPB, the surgery is set to begin after at least 15 minutes of block procedure. The intraoperative analgesic need will be supplied by fentanyl bolus doses as 50 mcq if necessary, as heart rate or systolic blood pressure increases by more than %15. According to randomization, the intervention group will receive RIFPB with 10 ml %0,25 bupivacaine.
From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS is over four or with the patient's request. The routine analgesia regimen was 1 gram IV paracetamol 6th hourly postoperatively at the PACU. All patients were followed up from the extubation time till hospital discharge to evaluate respiratory and hemodynamic changes, possible complications and total postoperative time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, triple-blind, controlled
| Arm | Type | Receives |
|---|---|---|
| The Control | No intervention | –The participants will have standardized anaesthesia management and receive postoperative rescue analgesia as morphine. |
| The rectointercostal fascial plane block | Experimental | Procedure: The recto intercostal fascial plane blockThe participants will receive postoperative recto intercostal fascial plane block, with 20 ml 0,25 bupivacaine bilaterally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who will undergo CABG surgery with sternotomy
- patients who have an American Society of Anesthesiologists (ASA) Physical Status classification of III to IV
Key exclusion criteria (8 listed)
- refusal to participate
- a history of neurological deficits or neuropathy affecting the thoracal innervation
- infection at the site of block application
- allergy to local anesthetics
- epilepsy or treatment with antipsychotics
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 |
|---|---|---|
| The recto intercostal fascial plane blockAfter ensuring aseptic conditions, the high-frequency linear ultrasound probe was used to detect the rectus abdominis muscle and the 6-7th costal cartilage as described by Tulgar et al. After rotating and shifting the transducer, 6-7th costal cartilages, the rectus abdominis muscle, and intercostal muscles between the cartilages were confirmed. The primary investigator (B.C.) directed the needle tip caudad in the cephalic direction in-plainly, and 20 ml 0,25% bupivacaine was injected bilaterally into the plane between the costal cartilage and the rectus abdominis muscle following negative aspiration. | Procedure or surgery | The rectointercostal fascial plane block |
Primary outcome
Total rescue analgesic
Time frame: postoperative 24 hour
. From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS over 4 or with the patient's request.
4 secondary outcomes
intraoperative opioid use
Time frame: intraoperative
intraoperative hemodynamic change
Time frame: at sternotomy
postoperative respiratory function
Time frame: postoperative 48 hour
postoperative arythmias
Time frame: postoperative 48 hour
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 19 Mar 2025.
- Background: PubMed 37295124Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
- Background: PubMed 38375661Chen Y, Li Q, Liao Y, Wang X, Zhan MY, Li YY, Liu GJ, Xiao L. Preemptive deep parasternal intercostal plane block for perioperative analgesia in coronary artery bypass grafting with sternotomy: a randomized, observer-blind, controlled study. Ann Med. 2023;55(2):2302983. doi: 10.1080/07853890.2024.2302983. Epub 2024 Feb 20.
- 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.
Berna Caliskan principal investigator
Haseki Training and Research Hospital Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The recto intercostal fascial plane block in people with Coronary Artery Disease and Peripheral Nerve Blocks, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 8 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. 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 Turkey (Türkiye). 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?
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 rescue analgesic (time frame: postoperative 24 hour). 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 NCT06418100, which also lists 2 linked publications.
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 19 Mar 2025.