Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery

February 11, 2026 updated by: Bahadir Ciftci, Medipol University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Burak Omur, Assist Prof, MD
  • Phone Number: +9050562150556

Study Locations

  • Turkey (Türkiye)
    • Bagcilar
      • Istanbul, Bagcilar, Turkey (Türkiye), 34070
        • Istanbul Medipol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-III
  • Scheduled for cardiac surgery with elective median sternotomy under general anesthesia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group PR = RIFPB and PIFB group
Recto-intercostal fascial plane block (RIFPB) and Pecto-intercostal fascial plane block (PIFB) will be applied
Drug: RIFPB block
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).
Other: Postoperative analgesia management

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.

Drug: PIFPB block
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).
Other: Group Control
No block will be applied.
Other: Postoperative analgesia management

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Postoperative 24 hours period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The use of rescue analgesia
Time Frame: Postoperative 24 hours period
Tramadol using (Number of Participants using)
Postoperative 24 hours period
The use of rescue analgesia
Time Frame: Postoperative 24 hours period
Tramadol using (Concentration of tramodol)
Postoperative 24 hours period
Global recovery scoring system / Quality of Recovery 15 questionairre
Time Frame: Change from baseline score at postoperative 24 hour
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.
Change from baseline score at postoperative 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Medipol Hospital 36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Disease

Clinical Trials on RIFPB block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings