Cardiovascular SurgeryNCT07622823
Fascial Plane Blocks In Cardiac Surgery
An observational study of Cardiovascular Surgery and Regional Anaesthesia, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to evaluate the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgery, Regional Anaesthesia, Postoperative Analgesia
- What is being tested?
- PIFPB + RIFPB and PIFPB + RSB
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to include ASA score I-IIII adult patients who are scheduled to elective cardiac surgery
Who may be able to join
- elective cardiac surgery planned
- over 18 years, adult
- American Society of Anaesthesiology (ASA) score I-III
Who cannot join
- under 18 years of age,
- ASA IV and above,
- contraindications for the block application
- history of cardiac surgery,
- reoperated due to surgery-related complications after emergency surgery or postoperative elective surgery,
- off-pump cardiac surgery or minimally invasive cardiac surgery
Show all 10Show fewer
- unable to be extubated in the intensive care unit at 24 hours postoperatively
- history of chronic pain treatment
- chronic alcoholism and substance abuse
- declining to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Antalya Training and Research Hospital
Antalya
About this study
Official title: The Effect Of Combined Rectus-Intercostal Fascial Plane Block Or Rectus Sheatf Block With A Pectoral-Intercostal Fascial Plane Block In Cardiac Surgery On Postoperative Opioid Consumption, Quality Of Recovery, And Chronic Pain: A Prospective, Observational Study
The aim of the present study is to evaluate the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in patients undergoing cardiac surgery.
Read the detailed description
Effective pain management after cardiac surgery is crucial in improving patient outcomes, promoting early postoperative mobilisation and minimising the risk of postoperative respiratory complications. It has indeed been shown that these patients experience moderate to severe pain during the postoperative period. While opioids are commonly used in perioperative care, they are also linked to adverse opioid-related effects. The literature suggests selecting an analgesic treatment strategy that avoids opioid-based analgesia for patients undergoing cardiac surgery during the postoperative period. Regional anaesthesia techniques are widely used in cardiac surgery patients to address concerns about the risk of myocardial and/or renal damage associated with non-steroidal anti-inflammatory drugs (NSAIDs), reduce the incidence of potential opioid-related side effects, lower the high risk of delirium and improve patient rehabilitation. However, only a limited number of studies have demonstrated the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in cardiac surgery patients. Therefore, the present study aims to evaluate the effects of the RIFPB or the RSB combined with the PIFPB on postoperative analgesia in patients undergoing cardiac surgery.
- Being tested
- PIFPB + RIFPB, PIFPB + RSB, Control
- Keywords
- cardiovascular surgery, pectoral-intercostal fascial plane block, recto-intercostal fascial plane block, rectus sheath block, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIFPB + RIFPBOther
The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.
PIFPB + RSBOther
The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.
ControlOther
Regional anesthesia is not applied.
| Study group | Role | What they receive |
|---|---|---|
| PIFPB+RIFPB | Not described Receives: Other: PIFPB + RIFPB | |
| PIFPB+RSB | Not described Receives: Other: PIFPB + RSB | |
| Control | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
Measured: 48 hours
Secondary outcomes (3)
postoperative recovery quality
TThe Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess poetoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the erly postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points.
Measured: 24 hours
postoperative pain scores
The NRS score (0=no pain; 10=most severe pain) will be used to assess postoperative pain
Measured: 48 hours
chronic pain
Patients will be telephoned 3 months after the operation and the presence, localization, and intensity of the pain, its character, and its relation with rest and/or activity will be recorded by asking only verbally. The NRS score (0=no pain; 10=most severe pain) will be used to assess postoperative pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (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 Cardiovascular SurgeryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arzu Karaveli, Principal investigator, University of Health Sciences, Antalya Training and Research HospitalCeren Nida Kural, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622823
- Sponsor's protocol ID
- 7/20
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grant MC, Gregory AJ, Ouanes JP. Regional analgesia for cardiac surgery. Curr Opin Anaesthesiol. 2022 Oct 1;35(5):605-612. doi: 10.1097/ACO.0000000000001169. Epub 2022 Jul 27.
PubMed 35900740Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1.
PubMed 38836555
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Combined Rectus-Intercostal Fascial Plane Block Or Rectus Sheatf Block With A Pectoral-Intercostal Fascial Plane Block In Cardiac Surgery On Postoperative Opioid Consumption, Quality Of Recovery, And Chronic Pain: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07622823
- Acronym / sponsor ID
- 7/20
- Keywords
- cardiovascular surgery, pectoral-intercostal fascial plane block, recto-intercostal fascial plane block, rectus sheath block, postoperative analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jun 2026 (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 aim of the present study is to evaluate the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in patients undergoing cardiac surgery.
Detailed description
Effective pain management after cardiac surgery is crucial in improving patient outcomes, promoting early postoperative mobilisation and minimising the risk of postoperative respiratory complications. It has indeed been shown that these patients experience moderate to severe pain during the postoperative period. While opioids are commonly used in perioperative care, they are also linked to adverse opioid-related effects. The literature suggests selecting an analgesic treatment strategy that avoids opioid-based analgesia for patients undergoing cardiac surgery during the postoperative period. Regional anaesthesia techniques are widely used in cardiac surgery patients to address concerns about the risk of myocardial and/or renal damage associated with non-steroidal anti-inflammatory drugs (NSAIDs), reduce the incidence of potential opioid-related side effects, lower the high risk of delirium and improve patient rehabilitation. However, only a limited number of studies have demonstrated the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in cardiac surgery patients. Therefore, the present study aims to evaluate the effects of the RIFPB or the RSB combined with the PIFPB on postoperative analgesia in patients undergoing cardiac surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PIFPB+RIFPB | – | Other: PIFPB + RIFPB |
| PIFPB+RSB | – | Other: PIFPB + RSB |
| Control | – | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include ASA score I-IIII adult patients who are scheduled to elective cardiac surgery
Key inclusion criteria (3 listed)
- elective cardiac surgery planned
- over 18 years, adult
- American Society of Anaesthesiology (ASA) score I-III
Key exclusion criteria (10 listed)
- under 18 years of age,
- ASA IV and above,
- contraindications for the block application
- history of cardiac surgery,
- reoperated due to surgery-related complications after emergency surgery or postoperative elective surgery,
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 |
|---|---|---|
| PIFPB + RIFPBThe procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring. | Other | PIFPB+RIFPB |
| PIFPB + RSBThe procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring. | Other | PIFPB+RSB |
| ControlRegional anesthesia is not applied. | Other | Control |
Primary outcome
postoperative opioid consumption
Time frame: 48 hours
3 secondary outcomes
postoperative recovery quality
Time frame: 24 hours
postoperative pain scores
Time frame: 48 hours
chronic pain
Time frame: 3 months
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 3 Jun 2026.
- Background: PubMed 35900740Grant MC, Gregory AJ, Ouanes JP. Regional analgesia for cardiac surgery. Curr Opin Anaesthesiol. 2022 Oct 1;35(5):605-612. doi: 10.1097/ACO.0000000000001169. Epub 2022 Jul 27.
- Background: PubMed 38836555Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Surgery
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
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.
Arzu Karaveli principal investigator
University of Health Sciences, Antalya Training and Research Hospital
Ceren Nida Kural principal investigator
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Surgery and Regional Anaesthesia, run by Antalya Health Sciences 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Jun 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?
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?
Contact Arzu Karaveli (+905325611300, arzukaraveli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption (time frame: 48 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 NCT07622823, 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 3 Jun 2026.