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Analgesic effect of intraosseous catheter placement in the anterior scalene muscle

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031240232
Enrollment
60
Registered
2024-07-24
Start date
2023-09-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post surgical pain in rotator cuff tears, contractures and osteoarthritis of the shoulder joint.

Interventions

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

Sponsors

Nakazawa Keisuke
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Contacts

Public ContactKeisuke Nakazawa

Nihon University School of Medicine Itabashi Hospital

nakazawa.keisuke@nihon-u.ac.jp+81-3-3972-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026