Sternotomy PIFB Block in Open Heart Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
  • Pecto-intercostal Fascial Block with normal saline

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators