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Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Using pectointercostal and other fascial plane nerve blocks to improve recovery after open‑heart (sternotomy) surgery

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

Run by Ordu University · NCT07557108 · Data updated 2026-11-12

This study will test whether adding ultrasound‑guided pectointercostal and related fascial plane nerve blocks to standard care speeds recovery and reduces pain for adults having elective open‑heart surgery through a median sternotomy.

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Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment123 (estimated)
SponsorOrdu University
Academic / other
Locations1 site (Ordu, Altinordu)
StatusRecruiting
StartedApril 5, 2026
Main results expectedDecember 5, 2026
Study endsDecember 20, 2026
Registry record updatedMay 4, 2026
Trial IDNCT07557108 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–70 having elective on‑pump open‑heart surgery by median sternotomy with ASA class II–III, who can give informed consent and do not have contraindications such as coagulopathy or active infection at the block site, are ideal candidates.

Probably not a fit

Patients having off‑pump, emergency, or repeat cardiac surgery, those with BMI >35 kg/m², LVEF <40%, significant renal or hepatic insufficiency, coagulopathy, local infection, chronic pain conditions, or allergy to local anesthetics are unlikely to be eligible or to derive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing elective on‑pump open‑heart surgery through a median sternotomy are randomly assigned to receive one of several ultrasound‑guided fascial plane blocks (pectointercostal, rectus sheath, or recto‑intercostal) in addition to standard perioperative care. Blocks are performed under ultrasound guidance, and recovery is followed using validated quality‑of‑recovery measures, pain scores, and opioid consumption in the postoperative period. The protocol compares PIFB combined with other regional techniques versus alternative fascial plane approaches, with a specific non‑inferiority comparison planned between recto‑intercostal fascial block and rectus sheath block. Safety, block effectiveness, and feasibility (including timing and ease of application) are recorded alongside clinical recovery outcomes.

Why it matters

Potential benefit: If successful, these nerve blocks could reduce postoperative pain, lower opioid use, and speed early recovery after median sternotomy.

How similar studies have gone: Previous case series and small randomized studies of thoracic fascial plane blocks, including pectointercostal techniques, have shown promising reductions in sternotomy pain and opioid use, but large definitive trials are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where it's running

  • Name: Ordu University Training and Research Hospital
    Ordu, Altinordu, Turkey (Türkiye)     Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.