- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622823
Fascial Plane Blocks In Cardiac Surgery
June 1, 2026 updated by: Antalya Health Sciences University
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
90
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
- Name: Arzu Karaveli
- Phone Number: +905325611300
- Email: arzukaraveli@hotmail.com
Study Locations
-
-
-
Antalya, Turkey (Türkiye)
- Recruiting
- University of Health Sciences, Antalya Training and Research 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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
It is planned to include ASA score I-IIII adult patients who are scheduled to elective cardiac surgery
Description
Inclusion Criteria:
- elective cardiac surgery planned
- over 18 years, adult
- American Society of Anaesthesiology (ASA) score I-III
Exclusion Criteria:
- 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
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
|
Regional anesthesia is not applied.
|
|
PIFPB+RIFPB
|
The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.
|
|
PIFPB+RSB
|
The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative opioid consumption
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative recovery quality
Time Frame: 24 hours
|
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.
|
24 hours
|
|
postoperative pain scores
Time Frame: 48 hours
|
The NRS score (0=no pain; 10=most severe pain) will be used to assess postoperative pain
|
48 hours
|
|
chronic pain
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arzu Karaveli, University of Health Sciences, Antalya Training and Research Hospital
- Principal Investigator: Ceren Nida Kural, University of Health Sciences, Antalya Training and Research Hospital
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
- Ciftci 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.
- 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.
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)
June 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
May 26, 2026
First Submitted That Met QC Criteria
June 1, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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