NCT07475884

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 17, 2026

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

fascial plane blockcardiac surgerymechanical ventilationicu lenght of stayoxygenation

Outcome Measures

Primary Outcomes (3)

  • Mechanical Ventilation Duration

    Total time on mechanical ventilator support in hours.

    Up to 72 hours postoperatively

  • Extubation Time

    Time from ICU admission to tracheal extubation in hours.

    Up to 48 hours postoperatively

  • ICU Length of Stay

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

    Up to 7 days postoperatively

Secondary Outcomes (4)

  • PaO₂/FiO₂ Ratio

    Postoperative 6th, 12th, and 24th hours

  • Postoperative Pain Score (VAS)

    Postoperative 6th, 12th, and 24th hours

  • Total Opioid Consumption

    First 24 hours postoperatively

  • Rescue Analgesic Requirement

    First 24 hours postoperatively

Study Arms (2)

Group 0 (Conventional Group)

group that does not have a block applied

Other: conventional analgesic regimen

Group 1 (Fascial Plane Group)

combined PIFB and SAPB group

Other: Fascial Plane Blocks

Interventions

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.

Group 0 (Conventional Group)

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.

Group 1 (Fascial Plane Group)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital,

Bursa, nilüfer, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

March 17, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Locations