Sternotomy PIFB Block in Open Heart Surgery

Launched by OHIO STATE UNIVERSITY · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Sternotomy PIFB Block in Open Heart Surgery," is studying a new way to help manage pain for patients undergoing heart surgery. The researchers want to see if using a specific nerve block technique called the Pecto-Intercostal Fascial Block (PIFB) with a local anesthetic (ropivacaine) can improve pain relief compared to a standard pain management approach. Participants will be randomly assigned to receive either the nerve block or a placebo (saline solution) in addition to the usual pain control methods. Their pain levels and any feelings of nausea will be assessed before and after surgery, with follow-up calls to check on their recovery at 30, 60, and 90 days.

To be eligible for this study, participants must be adults over 18 years old who are scheduled for heart surgery that requires an incision in the chest (sternotomy). They should also be able to read, write, and speak English, and provide informed consent. However, individuals with certain health conditions, like severe obesity, diabetes with nerve pain, or previous heart surgeries, may not qualify. This trial is currently recruiting participants, and it aims to find a more effective way to manage pain after heart surgery, potentially improving overall recovery experiences for patients.

Gender

ALL

Eligibility 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