臨床研究等提出・公開システム

Analgesic effect of intraosseous catheter placement in the anterior scalene muscle during brachial plexus block

Analgesic effect of intraosseous catheter placement in the anterior scalene muscle

Nakazawa Keisuke

Nihon University School of Medicine Itabashi Hospital

30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo

nakazawa.keisuke@nihon-u.ac.jp

Nakazawa Keisuke

Nihon University School of Medicine Itabashi Hospital

30-1, Oyaguchi Kami-cho, 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 in rotator cuff tears, contractures and osteoarthritis of the shoulder joint.

In the intervention group, a continuous catheter is placed in the middle scalene muscle near the interscalene groove after intramuscular brachial plexus block. The control group received a single dose of local anesthetic and no catheter placement.

Pain score (VAS scale: Visual Analogue Scale or NRS: Numerical rating scale) at 0, 2, 6, 12 (before sleep and after waking), 24, and 24 hours after surgery

Number of cases requiring additional rescue analgesia (NSAIDs, weak opioid analgesics) prescribed on the ward postoperatively and the time since surgery for which the additional analgesia was requested; presence of PONV (postoperative nausea and vomiting); vital signs (max/min/average blood pressure, respiratory rate, pulse rate) upon leaving the operating room; degree of muscle weakness by manual leg muscle strength degree of muscle weakness by lower leg manual muscle strength test. Time (in days) to rehabilitation ambulation. Number of days in hospital. Presence or absence of postoperative delirium. Presence or absence of sleep disturbance.

+81-3-3972-8111

Oct. 06, 2023

No

none