臨床研究等提出・公開システム

Study of Plasma Local Anesthetic Concentrations in Parasternal Intercostal Nerve Block and Transverse Thoracic Membrane Block

Clinical Effects of Parasternal Intercostal Nerve Block and Transversus Thoracis Plane Block

Nakazawa Keisuke

Nihon University School of Medicine Itabashi Hospital

30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo

nakazawa.keisuke@nihon-u.ac.jp

Nakazawa Keisuke

Nihon University School of Medicine Itabashi Hospital

30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo

+81-3-3972-8111

nakazawa.keisuke@nihon-u.ac.jp

Not Recruiting

July. 24, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Adults 20 years of age or older
2) Those who fall under BMI 18.5 to 25.0 kg/m2
3) Patients with American Society of Anesthesiologists Pre-Anesthesia Risk Assessment (ASA-PS) 3 or less (ASA-PS Classification 1: No organic, biochemical or psychiatric abnormalities. Classification 2: Mild to moderate systematic impairment. Classification 3: Severe systematic disorder. Classification 4: Severe, life-threatening systemic disorders that cannot be cured by surgery (Classification 5: Dying). Classification 5: Dying.)
4) Persons who give written consent to participate in the research.

1) Patients who do not meet the above selection criteria
2) Patients allergic to amide-type local anesthetics
3) Patients on anticoagulation therapy with PT-INR (Prothrombin Time International Normalized Ratio) > 1.2 or on dual anti-platelet therapy (DAPT), excluding biaaspirin monotherapy and prophylactic low molecular weight heparin therapy
4) Patients with any of the contraindications listed in the package insert.
5) Patients with moderate to severe hepatic dysfunction
6) Patients with arrhythmia requiring pacemaker insertion
7) Patients who meet all of the above selection criteria and none of the above exclusion criteria.
8) Patients who have refused to participate in this study.

Post Surgical Pain at Cardiovascular surgery case with median sternotomy

Two types of sternal fasciocutaneous surface blocks performed near the sternum are performed and the blood local anesthetic concentration is measured at a defined time after injection of the local anesthetic. The maximum blood concentration of local anesthetic Cmax and the time to reach the maximum blood concentration Tmax (min) will be measured and compared for parasternal intercostal nerve block and transverse thoracic fascial plane block.

Determine the maximum blood concentration of local anesthetics, C max, and the time to reach the maximum blood concentration, Tmax (min), from the values of ropivacaine blood concentration at 5min, 10min, 15min, 30min, 45min, 60min, 90min, and 120 minutes after nerve block

Intubation time in the intensive care unit, post-extubation patient pain score VAS or NRS (2 hours, 6 hours, morning after surgery, 24 hours after extubation), record of analgesic use, presence of PONV, vital signs on leaving the operating room (max/min/average blood pressure, respiratory rate, pulse rate), and other information obtained from electronic anesthesia records Patient information and treatment details, number of cases requiring additional prescriptions for rescue analgesia (NSAIDs, weak opioid analgesics) in the intensive care unit, and time since awake extubation when the additional analgesia was requested.

+81-3-3972-8111

Oct. 06, 2023

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