Bilateral serratus posterior superior intercostal plane block for pain after on‑pump open‑heart surgery
Official title: Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Acute Pain Management in Open-Heart Surgery
Run by Ondokuz Mayıs University · NCT07164677 · Data updated 2026-11-12
This trial will test whether a bilateral serratus posterior superior intercostal plane (SPSIP) block can reduce acute postoperative pain and opioid use in adults having on‑pump open‑heart surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ondokuz Mayıs University Academic / other |
| Locations | 1 site (Samsun) |
| Status | Recruiting |
| Started | September 13, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07164677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 scheduled for elective on‑pump open‑heart surgery via median sternotomy with ASA II–III who can use PCA and have no contraindication to regional anesthesia are ideal candidates.
✕Probably not a fit
Patients with long‑term opioid use, chronic pain syndromes, significant organ dysfunction, coagulation disorders, obstructive sleep apnea, or other listed contraindications are unlikely to benefit from this intervention.
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 median sternotomy are assigned to receive either an ultrasound‑guided bilateral SPSIP block or a sham block, and all receive IV morphine patient‑controlled analgesia after surgery. Pain scores, cumulative morphine consumption, quality of recovery, and opioid‑related side effects are recorded within the first 24 hours after surgery. The SPSIP block is a recently described fascial plane technique that may provide broad thoracic dermatomal coverage and an alternative to neuraxial approaches in anticoagulated patients. Standard exclusion criteria include chronic opioid use, significant organ dysfunction, coagulation disorders, severe psychiatric illness, pregnancy, and emergency or redo surgeries.
Why it matters
Potential benefit: If effective, the SPSIP block could lower early postoperative pain and opioid requirements, helping patients recover faster after cardiac surgery.
How similar studies have gone: Other fascial plane chest‑wall blocks (for example serratus anterior, parasternal, and erector spinae blocks) have shown promising opioid‑sparing effects in thoracic and cardiac procedures, but the SPSIP block itself is very new and has limited published outcome data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy. * American Society of Anesthesiologists (ASA) classification II-III patients. * Patients who can use PCA. * Patients who will sign the informed consent form. Exclusion Criteria: * History of opioid use for more than four weeks * Chronic pain syndromes * Patients with a history of local anesthetic or opioid allergy, hypersensitivity * Alcohol and drug addiction * Conditions where regional anesthesia is contraindicated * Failure in the dermatomal examination performed after the block * Emergency surgeries and redo surgeries. * Individuals with obstructive sleep apnea. * Left ventricular ejection fraction less than 30%. * Patients with severe psychiatric illnesses (such as psychosis, dementia) that limit cooperation with verbal numerical pain scales. * Pregnant and breastfeeding patients. * Hematological disorders. * Significant impairment in the function of a major organ (e.g., severe hepatic or renal disease). • Patients who cannot be extubated within the first 6 hours postoperatively.
Where it's running
-
Burhan Dost
Samsun, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Burhan Dost
- Email: burhandost@hotmail.com
- Phone: 05327042493
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.