Serratus Posterior Superior Intercostal Plane Block to Ease Pain After Minimally Invasive Valve Surgery
Official title: Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Patients Undergoing Minimally Invasive Cardiac Valve Surgery Via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial
Run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · NCT07588230 · Data updated 2026-11-12
This study tests whether the SPSIP block with local anesthetic can lower pain and reduce opioid use after minimally invasive heart valve surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital Academic / other |
| Locations | 1 site (Diyarbakır, Outside of the US) |
| Status | Recruiting |
| Started | May 16, 2026 |
| Main results expected | December 25, 2026 |
| Study ends | December 26, 2026 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07588230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with ASA I-III undergoing elective minimally invasive cardiac valve surgery via mini-thoracotomy and able to use the Numeric Rating Scale for pain.
✕Probably not a fit
Patients with contraindications to local anesthetics, chronic opioid users, severe pulmonary disease, coagulopathy, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled trial examines the analgesic effect of the serratus posterior superior intercostal plane (SPSIP) block in adults undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Participants are randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or saline, in addition to standard anesthesia and multimodal analgesia. Blinding is maintained for patients and outcome assessors to ensure unbiased assessment of pain and opioid consumption. The study aims to determine if the local anesthetic SPSIP block reduces postoperative opioid needs and improves pain control compared with placebo.
Why it matters
Potential benefit: If successful, patients may experience better pain control and lower opioid requirements after surgery.
How similar studies have gone: Previous regional anesthesia studies in thoracic surgery show potential for improved analgesia with plane blocks, though outcomes vary by technique and setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18-75 years * ASA physical status I-III * Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy * Able to understand and use the Numeric Rating Scale (NRS) * Provided written informed consent Exclusion Criteria: * Age \>75 years * Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine) * Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued * Infection at the planned block site * Chronic opioid use or chronic pain conditions * Severe pulmonary disease affecting respiratory assessment * Neurological or psychiatric disorders interfering with pain assessment * Emergency surgery * Pregnancy or breastfeeding * Refusal to participate
Where it's running
-
Fatma Acil
Diyarbakır, Outside of the US, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Fatma Acil, M.D. — Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Study coordinator: Fatma Acil, M.D.
- Email: acilfatma@gmail.com
- Phone: +905337225225
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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.