IV pain medicine, thoracic epidural, and erector spinae plane block for long-term pain after open-heart surgery
A Comparative Evaluation of Intravenous Analgesia, Thoracic Epidural Analgesia, and Erector Spinae Plane Block on Chronic Postoperative Pain Following Open Heart Surgery
This study will compare three common pain-control approaches—IV pain medicines, thoracic epidural, and erector spinae plane block—to see if one lowers chronic pain three months after open-heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Karadeniz Technical University Academic / other |
| Locations | 1 site (Trabzon, Trabzon) |
| Trial ID | NCT07257744 on ClinicalTrials.gov |
What this trial studies
This prospective observational study compares three routinely used postoperative analgesia methods—intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB)—in adults undergoing open-heart surgery via median sternotomy. No interventions are assigned by the protocol; patients receive the analgesia chosen by the treating anesthesia team, reflecting real-world practice at a single tertiary cardiac center. The primary outcome is chronic postoperative pain at 3 months measured with the Numeric Rating Scale and the S-LANSS questionnaire, collected by telephone or in-person follow-up. Secondary outcomes include acute postoperative pain scores, additional analgesic consumption, extubation and mobilization times, ICU and hospital length of stay, respiratory complications, and perioperative hemodynamic and related parameters.
Who should consider this trial
Good fit: Adults 18–85 years old with ASA physical status I–III scheduled for open-heart surgery via median sternotomy, BMI <35 kg/m², able to give informed consent and eligible for IV analgesia, TEA, or ESPB are the ideal candidates.
Not a fit: Patients with coagulation disorders, infection at the intervention site, prior open-heart surgery, chronic use of pain medications or certain psychiatric/communication limitations are unlikely to be eligible or to gain useful comparison data from this study.
Why it matters
Potential benefit: If one method is linked to lower rates of chronic pain, clinicians could preferentially use that approach to reduce long-term post-sternotomy discomfort.
How similar studies have performed: Previous work shows thoracic epidural and other regional techniques can reduce acute post-sternotomy pain and there is growing but mixed evidence about ESPB's effect on chronic pain, so direct comparative data for long-term outcomes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 85 years * Classified as ASA physical status I-III * Scheduled to undergo open heart surgery with median sternotomy * BMI \< 35 kg/m² * Able to understand and provide written informed consent * Eligible to receive any of the routine analgesia methods (intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block) Exclusion Criteria: * Age \< 18 or \> 85 years * BMI ≥ 35 kg/m² * Coagulation disorders * Infection at the intervention site * Known allergy to local anesthetics or induction agents * Psychiatric disorders limiting cooperation * Use of chronic pain medications, antidepressants, corticosteroids, antiepileptics, or routine analgesics * Inability to cooperate, communicate, or follow commands * Physical or verbal performance impairment * Previous open heart surgery
Where this trial is running
Trabzon, Trabzon
- Karadeniz Technical University Farabi Hospital — Trabzon, Trabzon, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ali AKDOGAN, MD
- Email: draliakdogan@yahoo.com
- Phone: +905322605414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.