Cardiac DiseaseNCT06285773
Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery
A study testing RIFPB block, Postoperative analgesia management and PIFPB block in people with Cardiac Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- RIFPB block, Postoperative analgesia management and PIFPB block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 20 Apr 2025
- 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
- American Society of Anesthesiologists (ASA) classification I-III
- Scheduled for cardiac surgery with elective median sternotomy under general anesthesia
Who cannot join
- a personal or family history of malignant hyperthermia,
- opioid sensitivity,
- alcohol or drug addiction,
- liver or kidney disease,
- skin infection in the area to be blocked,
- thoracic deformity,
- patients who are allergic to their medications,
- patients who do not agree to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Efficacy of Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery
In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.
Read the detailed description
Open heart surgery is defined as surgery performed on the heart valves, arteries, and other heart structures by cutting the sternum with a median sternotomy. Cardiovascular diseases are prevalent in the general global population and affect most of the older adult population. With the increase in life expectancy in recent years, there has been a significant increase in surgical procedures for cardiovascular diseases. ERAS recommends effective perioperative pain control to improve outcomes after Cardiac Surgery. Inadequate pain control after open heart surgery causes decreased mobilization, increased respiratory complications, prolonged hospital stays, and chronic pain.
Post-heart surgery pain is most intense during the first two days and then decreases. Considering that 17% of patients report chronic pain after cardiac surgery, it is crucial to provide effective analgesia in the early postoperative period.
Failure to adequately relieve post-operative pain may lead to increased pulmonary complications as a result of inability to breathe deeply, coughing due to fear of pain, and consequent inability to clear bronchial secretions. Moreover, increased endogenous catecholamines due to surgery and pain increase the heart's oxygen consumption by causing tachycardia and hypertension. This situation causes ischemia, heart failure, and arrhythmias in patients who have undergone cardiac surgery.
In general, postoperative pain is reduced with opioids, which can cause various complications. Although the use of opioids is recommended in cardiac surgery due to their ischemic effects, multimodal perioperative pain management strategies are recommended in current anesthesia. The use of regional anesthesia as part of multimodal strategies is steadily increasing in cardiac surgeries performed through median sternotomy. Despite multimodal analgesia strategies using regional techniques, post-operative pain still emerges as an important problem in open heart surgery with median sternotomy.
The leading causes of pain after cardiac surgery are; sternotomy incisions, chest retraction, dissection of the internal mammary artery, thoracic tubes, sternal wires, and visceral pain. Sternal pain is transmitted through intercostal nerves originating from T2-T6 spinal nerve roots, whereas various regional techniques are used for analgesia in parasternal region surgeries. Amongst these techniques, while parasternal blocks can be preferred as fascial plane blocks, these aim to block the anterior cutaneous branches of the T2-T6 thoracic nerves. Pectointercostal fascial block (PIFB) is an effective technique for controlling sternal pain in heart surgeries where median sternotomy is performed.
In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.
- Conditions
- Cardiac Disease
- Being tested
- RIFPB block, Postoperative analgesia management, PIFPB block
- Keywords
- Cardiac surgery, Postoperative analgesia management, Recto-intercostal fascial plane block, Pecto-intercostal fascial plane block
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIFPB blockDrug
For RIFPB, a local anesthetic will be injected into the plane between the costal cartilage and the rectus abdominis muscle at the 6th-7th costal cartilage under US guidance. The in-plane technique will be used. After confirming the block location, 10 ml of 0.25% concentration marcaine (bupivacaine) will be used (bilateral).
Postoperative analgesia managementOther
Patients will be administered 10mg/kg paracetamol in the postoperative period every eight hours.
If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administered as a rescue analgesic.
PIFPB blockDrug
For PIFPB; the ultrasound probe for PIFB is placed 2-3 cm lateral to the upper third of the sternum, parallel to the sternum. A local anesthetic of 15 ml of 0.25% concentration of marcaine (bupivacaine) will be used between the pectoralis major and external intercostal muscles (bilateral).
| Study group | Role | What they receive |
|---|---|---|
| Group PR = RIFPB and PIFB group | Active comparator | Recto-intercostal fascial plane block (RIFPB) and Pecto-intercostal fascial plane block (PIFB) will be applied Receives: Drug: RIFPB block; Other: Postoperative analgesia management; Drug: PIFPB block |
| Group Control | Other | No block will be applied. Receives: Other: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Change from Baseline Pain Scores at Postoperative 24 hours. Global QoR-15 Total: 150 (max) Physical Comfort 50 (max) Emotional State 40 (max) Psychological Support 20 (max) Physical Independence 20 (max) Pain 20 (max)
Measured: Postoperative 24 hours period
Secondary outcomes (3)
Global recovery scoring system / Quality of Recovery 15 questionairre
We will use the Turkish version of the Quality of Recovery / QoR-15 questionnaire. The QoR-15 ranges from 0-150 points. 0 points means the worst score, and 150 points means the best score.
Measured: Change from baseline score at postoperative 24 hour
The use of rescue analgesia
Tramadol using (Number of Participants using)
Measured: Postoperative 24 hours period
The use of rescue analgesia
Tramadol using (Concentration of tramodol)
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start10 Feb 2024
- Primary completion10 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Model description
- Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285773
- Sponsor's protocol ID
- Medipol Hospital 36
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
Zhang Y, Gong H, Zhan B, Chen S. Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2021 Jun 22;21(1):175. doi: 10.1186/s12871-021-01391-w.
PubMed 34157970Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.
PubMed 32798172Elbardan IM, Shehab AS, Mabrouk IM. Comparison of Transversus Thoracis Muscle Plane Block and Pecto-Intercostal Fascial Plane Block for enhanced recovery after pediatric open-heart surgery. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101230. doi: 10.1016/j.accpm.2023.101230. Epub 2023 Apr 7.
PubMed 37031816Tulgar 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 37295124
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06285773
- Acronym / sponsor ID
- Medipol Hospital 36
- Conditions
- Cardiac Disease
- Keywords
- Cardiac surgery, Postoperative analgesia management, Recto-intercostal fascial plane block, Pecto-intercostal fascial plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 29 Feb 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.
In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.
Detailed description
Open heart surgery is defined as surgery performed on the heart valves, arteries, and other heart structures by cutting the sternum with a median sternotomy. Cardiovascular diseases are prevalent in the general global population and affect most of the older adult population. With the increase in life expectancy in recent years, there has been a significant increase in surgical procedures for cardiovascular diseases. ERAS recommends effective perioperative pain control to improve outcomes after Cardiac Surgery. Inadequate pain control after open heart surgery causes decreased mobilization, increased respiratory complications, prolonged hospital stays, and chronic pain.
Post-heart surgery pain is most intense during the first two days and then decreases. Considering that 17% of patients report chronic pain after cardiac surgery, it is crucial to provide effective analgesia in the early postoperative period.
Failure to adequately relieve post-operative pain may lead to increased pulmonary complications as a result of inability to breathe deeply, coughing due to fear of pain, and consequent inability to clear bronchial secretions. Moreover, increased endogenous catecholamines due to surgery and pain increase the heart's oxygen consumption by causing tachycardia and hypertension. This situation causes ischemia, heart failure, and arrhythmias in patients who have undergone cardiac surgery.
In general, postoperative pain is reduced with opioids, which can cause various complications. Although the use of opioids is recommended in cardiac surgery due to their ischemic effects, multimodal perioperative pain management strategies are recommended in current anesthesia. The use of regional anesthesia as part of multimodal strategies is steadily increasing in cardiac surgeries performed through median sternotomy. Despite multimodal analgesia strategies using regional techniques, post-operative pain still emerges as an important problem in open heart surgery with median sternotomy.
The leading causes of pain after cardiac surgery are; sternotomy incisions, chest retraction, dissection of the internal mammary artery, thoracic tubes, sternal wires, and visceral pain. Sternal pain is transmitted through intercostal nerves originating from T2-T6 spinal nerve roots, whereas various regional techniques are used for analgesia in parasternal region surgeries. Amongst these techniques, while parasternal blocks can be preferred as fascial plane blocks, these aim to block the anterior cutaneous branches of the T2-T6 thoracic nerves. Pectointercostal fascial block (PIFB) is an effective technique for controlling sternal pain in heart surgeries where median sternotomy is performed.
In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room.
| Arm | Type | Receives |
|---|---|---|
| Group PR = RIFPB and PIFB group | Active comparator | Drug: RIFPB block, Other: Postoperative analgesia management, Drug: PIFPB blockRecto-intercostal fascial plane block (RIFPB) and Pecto-intercostal fascial plane block (PIFB) will be applied |
| Group Control | Other | Other: Postoperative analgesia managementNo block will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-III
- Scheduled for cardiac surgery with elective median sternotomy under general anesthesia
Key exclusion criteria (8 listed)
- a personal or family history of malignant hyperthermia,
- opioid sensitivity,
- alcohol or drug addiction,
- liver or kidney disease,
- skin infection in the area to be blocked,
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 |
|---|---|---|
| RIFPB blockFor RIFPB, a local anesthetic will be injected into the plane between the costal cartilage and the rectus abdominis muscle at the 6th-7th costal cartilage under US guidance. The in-plane technique will be used. After confirming the block location, 10 ml of 0.25% concentration marcaine (bupivacaine) will be used (bilateral). | Drug | Group PR = RIFPB and PIFB group |
| Postoperative analgesia managementPatients will be administered 10mg/kg paracetamol in the postoperative period every eight hours. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administered as a rescue analgesic. | Other | Group Control, Group PR = RIFPB and PIFB group |
| PIFPB blockFor PIFPB; the ultrasound probe for PIFB is placed 2-3 cm lateral to the upper third of the sternum, parallel to the sternum. A local anesthetic of 15 ml of 0.25% concentration of marcaine (bupivacaine) will be used between the pectoralis major and external intercostal muscles (bilateral). | Drug | Group PR = RIFPB and PIFB group |
Primary outcome
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Time frame: Postoperative 24 hours period
Change from Baseline Pain Scores at Postoperative 24 hours. Global QoR-15 Total: 150 (max) Physical Comfort 50 (max) Emotional State 40 (max) Psychological Support 20 (max) Physical Independence 20 (max) Pain 20 (max)
3 secondary outcomes
Global recovery scoring system / Quality of Recovery 15 questionairre
Time frame: Change from baseline score at postoperative 24 hour
The use of rescue analgesia
Time frame: Postoperative 24 hours period
The use of rescue analgesia
Time frame: Postoperative 24 hours period
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 13 Feb 2026.
- Background: PubMed 34157970Zhang Y, Gong H, Zhan B, Chen S. Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2021 Jun 22;21(1):175. doi: 10.1186/s12871-021-01391-w.
- Background: PubMed 32798172Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.
- Background: PubMed 37031816Elbardan IM, Shehab AS, Mabrouk IM. Comparison of Transversus Thoracis Muscle Plane Block and Pecto-Intercostal Fascial Plane Block for enhanced recovery after pediatric open-heart surgery. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101230. doi: 10.1016/j.accpm.2023.101230. Epub 2023 Apr 7.
- 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
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 study testing RIFPB block, Postoperative analgesia management and PIFPB block in people with Cardiac Disease, run by Medipol University 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: finished, as of the sponsor's last update on 13 Feb 2026. 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?
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?
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") (time frame: Postoperative 24 hours period). 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 NCT06285773, which also lists 4 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 13 Feb 2026.