An observational study in Cardiovascular Surgical Procedures, Pain, Postoperative and Cardiovascular Diseases, sponsored by Ordu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Ordu University · Observational
In this randomized trial, the investigators will test the hypothesis that combining regional analgesia techniques-which have the potential to improve the quality of postoperative recovery following median sternotomy-with PIFB will accelerate recovery. Additionally, it is anticipated that RIFB, an alternative fascial plane block, will demonstrate non-inferior (at least as effective as) performance compared to RSB, thereby providing flexibility and ease of application in clinical practice.
Advances in anesthesiology throughout the first quarter of the 21st century have significantly enhanced perioperative care quality and mitigated complication risks. In particular, ultrasound (US)-guided fascial plane blocks have become prominent and widely preferred methods for providing postoperative pain control in current practice. Today, fascial plane blocks form the cornerstone of multimodal analgesia strategies developed to avoid complications associated with neuraxial analgesia methods.
Thoracic fascial plane blocks (TFB) have become one of the revolutionary advancements in cardiac anesthesia practice and have been widely adopted in cardiac surgery patients.
The pectointercostal fascial plane block (PIFB), a type of TFB, was first described by De la Torre et al. in patients undergoing breast surgery. This new technique involves blocking the anterior cutaneous branches of the T2-6 intercostal nerves, which are responsible for sensory innervation of the sternal region.
PIFB is an effective method for controlling sternotomy pain in patients undergoing open-heart surgery. The technique offers several advantages, including its minimally invasive nature, its proximity to the sternotomy line, and the flexibility to be administered at any perioperative time point following anesthesia induction without requiring the patient to change position. Furthermore, unlike neuraxial analgesia techniques, this approach circumvents serious complications associated with neuraxial techniques, such as nerve injury, dural puncture, or epidural hematoma.
In addition to median sternotomy, chest drains placed in the subxiphoid region following cardiac surgery are also a significant source of postoperative pain. This pain may result from factors such as the skin incision, continuous irritation of surrounding tissues, and direct damage to the rectus abdominis muscle caused by the chest drains. Severe postoperative pain developing in the epigastric region can disrupt respiratory mechanics, increasing the risk of pulmonary complications and leading to a delay in the extubation process.
Although the rectus sheath block (RSB) is classified as a "Plan A" block among abdominal wall blocks, when combined with the PIFB, it can provide extensive analgesia in the anterior chest wall. Anatomically, the RSB targets the anterior cutaneous branches of the T7-12 intercostal nerves, providing somatic analgesia to the anteromedial abdominal wall and the periumbilical region. In other words, the RSB can play a complementary role in analgesic efficacy by targeting areas outside the PIFB's area of effect.
In this context, RSB has become a complementary and critical component of a multimodal analgesia strategy when combined with PIFB for the management of pain associated with median sternotomy and subxiphoid thoracic drains in cardiac surgery patients.
Recently, the rectointercostal fascial plane block (RIFB) has been described as a complementary block following sternotomy, providing analgesic efficacy similar to the RSB, particularly in the subxiphoid region. The RIFB provides effective analgesia in the subxiphoid region by blocking the anterior and lateral cutaneous branches of the intercostal nerves originating at the T6-9 levels. Although it is a relatively new technique, the absence of reported complications in case reports and series in the literature suggests that RIFB represents a safe and viable alternative.
In recent studies on peripheral nerve blocks, the concept of "quality of recovery" has become a focal point among key endpoints. However, the effect of different TFB techniques used in perioperative cardiac surgical management on quality of recovery has not yet been clearly established.
A review of the literature indicates that while PIFB administered alone after cardiac surgery provides effective analgesia in the sternal region, it is limited in managing pain caused by thoracic drains, particularly in the subxiphoid region. It is anticipated that inadequate postoperative analgesia will negatively impact the quality of patient recovery.
In this randomized trial, the investigators will test the hypothesis that combining regional analgesia techniques-which have the potential to improve the quality of postoperative recovery following median sternotomy-with PIFB will accelerate recovery. Additionally, it is anticipated that RIFB, an alternative fascial plane block, will demonstrate non-inferior (at least as effective as) performance compared to RSB, thereby providing flexibility and ease of application in clinical practice.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 123 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
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Patients aged 18-70 years, with ASA physical status II-III, who are scheduled to undergo elective open-heart surgery via median sternotomy with cardiopulmonary bypass at a tertiary care city hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral pectointercostal fascial plane block (PIFB) will be administered.
Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block
Bilateral rectus sheath block (RSB) will be administered in addition to bilateral PIFB.
Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block · Procedure: Ultrasound-Guided Rectus Sheath Block
Bilateral retro-intercostal fascial plane block (RIFB) will be administered in addition to bilateral PIFB.
Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block · Procedure: Ultrasound-Guided Recto-Intercostal Fascial Plane Block
Following anesthesia induction, bilateral pectointercostal fascial plane block (PIFB) will be performed under steril conditions using a high-frequency linear US probe positioned parallel to the parasternal region. The second and fourth ribs will be identified in the parasternal region under US guidance. A 100-mm echogenic peripheral nerve block needle will be advanced craniocaudally toward the fourth rib using an in-plane technique to reach the fascial plane between the pectoralis major and intercostal muscles. After confirming the target plane via hydrodissection, 20 mL of 0.25% bupivacaine will be injected into the fascial plane on each side (total 40 mL). The success of the block will be confirmed by sliding the US probe craniocaudally to directly visualize the local anesthetic spread between the pectoralis major fascia and the intercostal muscles (extending from the first to the sixth rib).
Bilateral rectus sheath block (RSB) will be performed at the end of surgery. A high-frequency linear US probe will be positioned in the epigastric region, 2-3 cm below the xiphoid process and immediately below the chest tubes, intersecting the linea alba perpendicularly. After identifying the anatomical structures (anterior rectus abdominis sheath, muscle, posterior sheath, and peritoneum) with the US probe, a 100-mm echogenic peripheral block needle will be advanced into the plane between the rectus abdominis muscle and the posterior sheath using an in-plane technique. After confirming the needle tip location via hydrodissection, a total of 20 mL of 0.25% bupivacaine (10 mL per side) will be injected into the fascial plane. Block success will be confirmed by direct visualization of the "double V"-shaped echogenic pattern formed by the spread of the local anesthetic between the fascial planes.
Bilateral recto-intercostal fascial plane block (RIFB) will be performed at the end of surgery. A high-frequency linear US probe will be positioned in the sagittal plane, 3-4 cm lateral and 3-4 cm caudal to the xiphoid process. After identifying the sixth and seventh costal cartilages and the rectus abdominis muscle, a 100-mm echogenic peripheral block needle will be advanced caudo-cranially using an in-plane technique to reach the plane between the rectus abdominis muscle and the costal cartilage. After confirming the needle tip location via hydrodissection, a total of 20 mL of 0.25% bupivacaine (10 mL per side) will be injected into the fascial plane. Block success will be confirmed by direct visualization of the local anesthetic spread in a cranio-caudal direction.
Turkish version of the Quality of Recovery-15 scale (QoR-15T)
The QoR-15T scale consists of a total of 15 items, each scored on a 0-10 scale (a 11-point Likert-type scale). The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). While total scores of 118 and above are generally accepted in the literature as an indicator of 'good recovery,' scores can also be classified as 136-150 (excellent), 122-135 (good), 90-121 (moderate), and 0-89 (poor). The scale covers five domains: physical comfort (items 1-4 and 13), emotional state (items 9, 10, 14, and 15), psychological support (items 6 and 7), physical independence (items 5 and 8), and pain (items 11 and 12).
Time frame: In the postoperative period, the time of extubation will be considered "postoperative hour 0". The primary endpoint is the quality of early recovery, assessed at 24 hours postoperatively.
Turkish version of the Quality of Recovery-15 scale (QoR-15T)
The QoR-15T scale consists of a total of 15 items, each scored on a 0-10 scale (a 11-point Likert-type scale). The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). While total scores of 118 and above are generally accepted in the literature as an indicator of 'good recovery,' scores can also be classified as 136-150 (excellent), 122-135 (good), 90-121 (moderate), and 0-89 (poor). The scale covers five domains: physical comfort (items 1-4 and 13), emotional state (items 9, 10, 14, and 15), psychological support (items 6 and 7), physical independence (items 5 and 8), and pain (items 11 and 12).
Time frame: In the postoperative period, the time of extubation will be considered "postoperative hour 0". QoR-15T scores will be reassessed at 48 hours postoperatively and prior to discharge.
The Numerical Rating Scale (NRS)
NRS contains 11 digits that should be assigned according to the perceived pain intensity (0: no pain, 10: the most severe pain imaginable).
Time frame: All cases will be assessed using the NRS at 0, 3, 6, 12, 24, 36, and 48 hours after extubation.
Total Tramadol Consumption
A standard analgesia protocol will be administered to all patients for postoperative pain management. No additional opioids will be given between the end of surgery and extubation. Total tramadol consumption will be recorded during the first 48 hours post-extubation to evaluate opioid use. The postoperative observation phase of the study has been defined to encompass the first 48 hours following extubation.During the observation phase, patients with a Numerical Rating Scale (NRS) score of ≥4 will receive IV tramadol (1 mg/kg, max 400 mg/day) as rescue analgesia.
Time frame: Total tramadol consumption will be recorded during the first 48 hours post-extubation to evaluate opioid use.
Opioid-Related Adverse Effects During the Postoperative Observation Phase
Nausea, Vomiting, Pruritus, Constipation, Urinary Retention, and Arrhythmia
Time frame: Until hospital discharge (approximately 5-7 days)
Complications Associated with Fascial Plane Blocks
Vascular Puncture, Local Hematoma, Pneumothorax, and Infection at the Injection Site
Time frame: Until hospital discharge (approximately 5-7 days)
Plan to share: Undecided
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