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Fascial Plane BlockNCT07475884

Postoperative Analgesia and Ventilation After Cardiac Surgery

An observational study of Fascial Plane Block and ICU Length of Stay, run by Bursa City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiac surgery performed via median sternotomy is associated with significant postoperative pain due to extensive tissue trauma, sternal bone healing, and mediastinal retraction. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
conventional analgesic regimen and Fascial Plane Blocks
Type of treatment
Injection or infusion
How many people
206 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2025to 28 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: elective coronary artery bypass grafting (CABG) or heart valve surgery via sternotomy.

The study included patients aged 18-80 years who underwent elective coronary artery bypass grafting (CABG) or heart valve surgery via sternotomy.

Exclusion criteria were defined as follows: off-pump surgery, thoracotomy, reoperation (redo surgery), emergency surgical conditions, development of complications requiring surgical revision in the postoperative period, and incomplete perioperative data recording.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa City Hospital,

    Bursa, nilüfer

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Fascial Plane Blocks Providing Postoperative Analgesia on Mechanical Ventilation Duration in the Intensive Care Unit and Early Oxygenation After Cardiac Surgery

Cardiac surgery performed via median sternotomy is associated with significant postoperative pain due to extensive tissue trauma, sternal bone healing, and mediastinal retraction. Inadequately controlled postoperative pain represents an important source of morbidity in these patients and may adversely affect respiratory mechanics, leading to hypoventilation, atelectasis, and hypoxemia. These complications can delay extubation, prolong the duration of mechanical ventilation, and increase the length of stay in the intensive care unit (ICU). In addition, insufficient pain control may trigger sympathetic activation, resulting in increased myocardial oxygen consumption, a higher risk of arrhythmias, and impaired immune function. Traditionally, systemic opioids have been the cornerstone of postoperative pain management in cardiac surgery; however, opioid-based analgesia is associated with several adverse effects, including respiratory depression, sedation, nausea and vomiting, gastrointestinal dysfunction, and prolonged mechanical ventilation. These limitations have led to increasing interest in multimodal analgesia strategies aimed at improving postoperative pain control while reducing opioid consumption and related complications. In this context, regional analgesia techniques have emerged as important components of multimodal pain management protocols in cardiac surgery.

The aim of this study was to evaluate the effects of fascial plane blocks used as part of postoperative analgesia on postoperative pain control, opioid consumption, respiratory parameters, mechanical ventilation duration, and early oxygenation in patients undergoing open heart surgery via median sternotomy, compared with patients receiving conventional analgesic management.

Read the detailed description

Cardiac surgery is a major surgical discipline performed on hundreds of thousands of patients worldwide and is becoming increasingly common with technological advances. Median sternotomy remains the standard surgical approach for open-heart procedures, most notably coronary artery bypass grafting (CABG) and valve reconstruction or replacement.1,2 The pain resulting from sternotomy-associated extensive tissue injury, sternal bone regeneration, and mediastinal retraction is both severe and multidimensional in nature, arising from widespread irritation of the thoracic wall, pericardium, pleura, and the involved neural structures.3 Inadequately controlled postoperative pain is a significant source of morbidity in cardiac surgery and leads to serious clinical consequences. Acute pain adversely affects respiratory mechanics, predisposing patients to hypoventilation, atelectasis, and hypoxemia; it prolongs the extubation process and increases the duration of intensive care unit (ICU) stay.4,5 Insufficient analgesia can also increase myocardial oxygen demand through sympathetic activation, heighten susceptibility to arrhythmias, and compromise immunological integrity.6 In the long term, the risk of acute pain transitioning into chronic post-sternotomy pain cannot be overlooked; this condition is known to permanently impair patients' quality of life and significantly restrict functional capacity.7 Systemic opioids have traditionally formed the cornerstone of postoperative pain management in cardiac surgery. However, opioid-based analgesia is associated with a range of adverse effects including respiratory depression, sedation, nausea and vomiting, ileus, and prolonged mechanical ventilation.8 These adverse effects are particularly consequential in the vulnerable patient population of cardiac surgery, contributing to increased clinical complexity, greater utilization of hospital resources, and potential increases in mortality.9 In this context, multimodal analgesia strategies aimed at reducing opioid consumption, limiting side effects, and accelerating postoperative recovery are gaining increasing importance.10 Regional anesthesia techniques have been rapidly integrated into cardiac surgical practice in recent years as an indispensable component of multimodal analgesia protocols. Although thoracic epidural anesthesia and paravertebral block have long been established methods with proven efficacy, their use is significantly limited by factors such as coagulopathy, systemic heparinization in cardiac surgery, and high bleeding risk.11,12 Superficial fascial plane blocks, developed alongside the widespread adoption of ultrasound technology, offer a more favorable safety profile and are attracting increasing interest in cardiac surgical applications.13 The pecto-intercostal fascial plane block (PIFB) is a relatively novel technique based on local anesthetic injection into the fascial plane between the pectoralis major muscle and the external intercostal muscles. By targeting the intercostal nerve branches of the anterior thorax and afferent fibers of the cutaneous pectoral branches, PIFB provides effective analgesia along the sternotomy incision adjacent to the sternum.14,15 The serratus anterior plane block (SAPB), on the other hand, blocks the intercostobrachial nerve and thoracic intercostal nerve branches innervating the lateral thorax through local anesthetic injection into the fascial plane between the latissimus dorsi and serratus anterior muscles and the ribs.16,17 The combination of these two blocks establishes a complementary analgesic coverage encompassing the sternotomy incision, the parasternal region, and the lateral thoracic wall.18 Both techniques possess characteristics that distinguish them in cardiac surgical patients: superficial anatomical targets, ease of ultrasound-guided application, and a safe-use profile even during anticoagulation.19 Nevertheless, studies evaluating the combined application of PIFB and SAPB in open-heart surgery remain very limited in number, and comprehensive data assessing the impact of this combination on postoperative pain control, opioid consumption, and respiratory function are still insufficient.

The aim of this study is to evaluate the effect of fascial plane block on postoperative pain scores, opioid consumption, respiratory parameters, and ICU outcomes in patients undergoing open-heart surgery via sternotomy, in comparison with patients receiving conventional analgesia.

Being tested
conventional analgesic regimen, Fascial Plane Blocks
Keywords
fascial plane block, cardiac surgery, mechanical ventilation, icu lenght of stay, oxygenation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional analgesic regimenOther

    At the end of the surgery, wound site infiltration and IV paracetamol 1 g and IV tramadol 100 mg were administered for multimodal analgesia. During the follow-up period in the intensive care unit (ICU), IV paracetamol 1 g and IV tramadol 50 mg were routinely administered every 6 hours. The threshold value for rescue analgesia requirement was determined as Visual Analog Scale (VAS) ≥ 4; IV meperidine 100 mg was administered as a rescue dose to patients exceeding this threshold.

  • Fascial Plane BlocksOther

    PIFB: Under ultrasound guidance, 15 mL of 0.25% bupivacaine is injected bilaterally into the fascial plane between the pectoralis major and external intercostal muscles, 2-3 cm lateral to the sternal border.

    SAPB: Under ultrasound guidance, 15 mL of 0.25% bupivacaine is injected bilaterally into the fascial plane between the serratus anterior muscle and the ribs at the 4th-5th rib level in the midaxillary line.

    At the end of surgery, IV paracetamol 1 g and IV tramadol 100 mg were administered. In the ICU, IV paracetamol 1 g and IV tramadol 50 mg were given every 6 hours. Rescue analgesia (IV meperidine 100 mg) was administered for VAS ≥ 4.

Study groups in NCT07475884
Study groupRoleWhat they receive
Group 0 (Conventional Group)group that does not have a block applied
Receives: Other: conventional analgesic regimen
Group 1 (Fascial Plane Group)combined PIFB and SAPB group
Receives: Other: Fascial Plane Blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mechanical Ventilation Duration

    Total time on mechanical ventilator support in hours.

    Measured: Up to 72 hours postoperatively

  2. Extubation Time

    Time from ICU admission to tracheal extubation in hours.

    Measured: Up to 48 hours postoperatively

  3. ICU Length of Stay

    Duration of intensive care unit stay in hours, measured from ICU admission to discharge.

    Measured: Up to 7 days postoperatively

Secondary outcomes (4)
  1. PaO₂/FiO₂ Ratio

    Arterial oxygenation index calculated from arterial blood gas analysis.

    Measured: Postoperative 6th, 12th, and 24th hours

  2. Postoperative Pain Score (VAS)

    Pain intensity assessed using the Visual Analog Scale (0-10).

    Measured: Postoperative 6th, 12th, and 24th hours

  3. Total Opioid Consumption

    Cumulative opioid use expressed in morphine equivalents (mg)

    Measured: First 24 hours postoperatively

  4. Rescue Analgesic Requirement

    Number of rescue analgesic doses (IV meperidine 100 mg) administered for VAS ≥ 4.

    Measured: First 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start1 Jul 2025
  3. Primary completion31 Dec 2025
  4. Study completion28 Feb 2026

Resources

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
Retrospective
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07475884
Sponsor's protocol ID
2025-15/13
Status last verified
Aug 2025
First submitted
13 Mar 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Publications

  • 11. Kristensen SD, Knuuti J, Saraste A, et al. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management. Eur Heart J. 2014;35(35):2383-2431. 12. Fitzgibbon DR, Koyyalagunta D. A practical approach to acute pain management after cardiac surgery. ASA Refresher Courses Anesthesiol. 2010;38(1):37-48. 13. Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013;68(11):1107-1113. 14. Ueshima H, Otake H. Clinical experiences of pecto-intercostal fascial block for postoperative analgesia in cardiac surgery. J Clin Anesth. 2017;36:44-45. 15. Kaushal B, Chauhan S, Saini K, et al. Comparison of the efficacy of ultrasound-guided serratus anterior plane block, pectoral nerves II block, and local infiltration analgesia for management of postoperative pain and quality of recovery in patients undergoing modified radical mastectomy. J Clin Anesth. 2019;54:118-124. 16. Portela DA, Otero PE, Briganti A. Serratus anterior plane block in canine cadavers: anatomical evaluation. Vet Anaesth Analg. 2019;46(4):516-524. 17. Hong B, Yoon SH, Huh B, Lee S, Yoon JU, Byeon GJ. Serratus anterior plane block for refractory pain after cardiac surgery. Pain Physician. 2019;22(3):E219-E224. 18. Choudhary MK, Bhaware B, Bhui A, et al. Bilateral pecto-intercostal fascial plane block with serratus anterior plane block versus both blocks individually for post-median sternotomy analgesia: a randomized controlled trial. J Cardiothorac Vasc Anesth. 2022;36(9):3348-3356. 19. Ahmed Z, Ke J, Zhong Y, et al. Combined pecto-intercostal fascial block and serratus anterior plane block for analgesia after cardiac surgery: a retrospective cohort analysis. J Pain Res. 2023;16:1785-1794.

  • 1. Engelman DT, Ben Ali W, Williams JB, et al. Guidelines for perioperative care in cardiac surgery: Enhanced Recovery After Surgery Society recommendations. JAMA Surg. 2019;154(8):755-766. 2. Yildiz O, Doganci S. Cardiac surgery in Turkey: national database and current status. Turk Gogus Kalp Damar Cerrahisi Derg. 2020;28(1):1-6. 3. Muellejans B, Matthey-Doret D, Mey C, et al. Postoperative pain after cardiac surgery: a prospective cross-sectional multicentre cohort study. Eur J Anaesthesiol. 2021;38(2):134-142. 4. Thorpe SJ, Hyde R, Blackburn A. Pain management after cardiac surgery: an updated review. J Cardiothorac Vasc Anesth. 2021;35(9):2839-2851. 5. Richebe P, Capdevila X, Rivat C. Persistent postsurgical pain: pathophysiology and preventative pharmacologic considerations. Anesthesiology. 2018;129(3):590-607. 6. Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011;377(9784):2215-2225. 7. Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008;101(1):77-86. 8. Chu LF, Angst MS, Clark D. Opioid-induced hyperalgesia in humans: molecular mechanisms and clinical considerations. Clin J Pain. 2008;24(6):479-496. 9. De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012;114(2):424-433. 10. Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.

Questions about this trial

What is this clinical trial studying?

An observational study of Fascial Plane Block and ICU Length of Stay, run by Bursa City Hospital 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?

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: finished, as of the sponsor's last update on 17 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mechanical Ventilation Duration (time frame: Up to 72 hours postoperatively). The study lists 3 primary outcomes in all. 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 NCT07475884, 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 17 Mar 2026.

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