Cardiovascular Surgical ProceduresNCT07557108
Fascial Plane Blocks and Quality of Recovery in Cardiac Surgery
An observational study of Cardiovascular Surgical Procedures and Pain, Postoperative, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiovascular Surgical Procedures, Pain, Postoperative, Cardiovascular Diseases
- What is being tested?
- Ultrasound-Guided Pectointercostal Fascial Plane Block, Ultrasound-Guided Rectus Sheath Block and Ultrasound-Guided Recto-Intercostal Fascial Plane Block
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2026to 20 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients who have provided written informed consent
- Open-heart surgery performed under elective conditions via median sternotomy with cardiopulmonary bypass (on-pump)
- American Society of Anesthesiologists (ASA) physical status class II or III
- Aged 18-70 years
Who cannot join
- Off-pump surgical procedure
- Emergency or repeat cardiac surgery
- Known allergy to induction agents or local anesthetics
- Body mass index (BMI) >35 kg/m²
- Coagulopathy
- Infection at the surgical site
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- Left ventricular ejection fraction (LVEF) <40%
- Renal insufficiency (estimated glomerular filtration rate <60 mL/min/1.73 m²) or hepatic insufficiency [Presence of major systemic diseases such as acute decompensated cirrhosis characterized by bilirubin >12 mg/dL, INR >2.5, or hepatic encephalopathy, in accordance with the European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria]
- Psychiatric disorders
- History of chronic pain or regular use of analgesics (corticosteroids, analgesics, anticonvulsants)
- Cognitive impairments that could interfere with the assessment of postoperative pain
- Patients with impaired physical and verbal performance
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
Name: Ordu University Training and Research Hospital
Ordu, Altinordu, 52200
Yasir Ilyas, Assistant Professor, +905073460233, ysrilyas@outlook.com
About this study
Official title: Pecto-Intercostal Fascial Plane Block-Based Multimodal Analgesia to Improve Quality of Recovery After Median Sternotomy: A Randomized Non-Inferiority Trial Comparing Retro-Intercostal Fascial Plane Block and Rectus Sheath Block
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.
Read the detailed description
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.
- Being tested
- Ultrasound-Guided Pectointercostal Fascial Plane Block, Ultrasound-Guided Rectus Sheath Block, Ultrasound-Guided Recto-Intercostal Fascial Plane Block
- Keywords
- Cardiovascular Surgical Procedures, Anesthesia, Conduction, Acute Postoperative Pain, Pain Management, Enhanced Recovery After Surgery, Anesthesia, Regional
- Medical subject headings
- Pain, Postoperative, Cardiovascular Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Pectointercostal Fascial Plane BlockProcedure or surgery
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).
Ultrasound-Guided Rectus Sheath BlockProcedure or surgery
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.
Ultrasound-Guided Recto-Intercostal Fascial Plane BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Bilateral pectointercostal fascial plane block (PIFB) will be administered. Receives: Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block | |
| Group PRS | Bilateral rectus sheath block (RSB) will be administered in addition to bilateral PIFB. Receives: Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block; Procedure: Ultrasound-Guided Rectus Sheath Block | |
| Group PRI | Bilateral retro-intercostal fascial plane block (RIFB) will be administered in addition to bilateral PIFB. Receives: Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block; Procedure: Ultrasound-Guided Recto-Intercostal Fascial Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: Until hospital discharge (approximately 5-7 days)
Complications Associated with Fascial Plane Blocks
Vascular Puncture, Local Hematoma, Pneumothorax, and Infection at the Injection Site
Measured: Until hospital discharge (approximately 5-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 Apr 2026
- Primary completion5 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Surgical ProceduresStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasir Ilyas, MD, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557108
- Sponsor's protocol ID
- OrduU-AR-YI-01
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided