ASA-PS II-IV patients between 18 and 80 years of age scheduled to undergo open heart surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients undergoing cardiac surgery under median sternotomy. 2) Patients with American Society of Anesthesiologist(ASA)-physical status classification II-IV. 3) Patients who are 18 years old or older and younger than 80 years old at the time of obtaining consent. 4) Patients who have been fully informed of the study and who have given written consent of their own free will.
Exclusion criteria
Exclusion criteria: Patients with the following conditions will be excluded from the study 1) Previous median sternotomy 2) Deformity near the sternum (e.g., funnel chest) 3) Neuropathy near the puncture site 4) Nerve block puncture site infection 5) History of allergy to local anesthetics or drugs used for general anesthesia 6) Pregnancy 7) Emergency surgery 8) Heart failure with NYHA Classification IV symptoms 9) Pulmonary hypertension requiring inhalation of nitric oxide 10) Preoperative ventilatory management 11) Serious blood coagulation disorder (platelet count less than 50000/mcL, PT% less than 60%, APTT 15 seconds longer than control value) 12) Patients with serious systemic diseases 13) Cases of infective endocarditis 14) Patients on drugs that inhibit CYP1A2 15) Other patients deemed inappropriate as subjects by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the success or failure of transversus thoracic muscle plane block. Efficacy is judged as block failure if blood pressure or heart rate within 2 minutes after median sternotomy increases by more than 20% from the baseline value measured at the end of anesthesia induction, and as successful block if the increase is less than 20%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional narcotic analgesics (fentanyl/remifentanil) from post skin incision to completion of median sternotomy. Time from the end of the block to the midline sternotomy. Postoperative pain (NRS) score. The total amount of fentanyl and remifentanil used intraoperatively and postoperatively. Time to completion of ventilatory management. Postoperative ICU length of stay. Frequency of postoperative nausea and vomiting. Presence of postoperative complications (wound infection, pneumonia, etc.). Presence or absence of wound pain three months after surgery, (NRS pain score based on mailed questionnaire) . Changes in blood test results from preoperative period. | — |
Contacts
University of Tsukuba Hospital