Using a nerve block for pain control in open heart surgery
Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: a Randomized, Double-blind, Controlled Trial
This study is testing if a special pain relief method using a nerve block can help people feel less pain after open-heart surgery compared to a regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06233318 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a bilateral nerve block using ropivacaine as part of a multimodal analgesia regimen for patients undergoing open-heart surgery. Participants will be randomly assigned to receive either the nerve block or a saline placebo, and their pain and nausea levels will be assessed at multiple time points post-surgery. The study aims to determine if the nerve block can improve pain management outcomes compared to standard care. It is conducted at Richard M. Ross Hospital - The Ohio State University Medical Center, following strict institutional guidelines.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old, scheduled for primary cardiac surgery requiring sternotomy, and classified as ASA physical status I-IV.
Not a fit: Patients with cognitive disorders, diabetes with neuropathic pain, or those with contraindications to nerve blocks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and recovery for patients undergoing open-heart surgery.
How similar studies have performed: Other studies have shown promise in using nerve blocks for pain management in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult male or female patients aged \> 18 * Undergoing primary cardiac surgery requiring sternotomy * Able to provide a signed written informed consent * Able to speak, read, and write in English * American Society of Anesthesiologists (ASA) physical status I-IV Exclusion Criteria: * Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception * Diabetes Mellitus with documented neuropathic pain * Vulnerable populations: pregnant females, prisoners, breast feeding * Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone * Previous cardiac surgery * Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery * Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study * BMI ≥ 40 kg/m2
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Alberto A Uribe
- Email: alberto.uribe@osumc.edu
- Phone: 6142930775
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.