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Relationship between diabetics and local anesthetic concentrations.

Plasma local anesthetic concentrations after peripheral nerve blockade in diabetic patients. - Diabetes and local anesthetic testing

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054964
Enrollment
30
Registered
2024-07-15
Start date
2024-08-01
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

Hip joint surgery

Interventions

None listed

Sponsors

Nihon University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Adults aged 20 years and over. 2)Persons falling under BMI 18.5-25.0 kg/m2. 3)Patients with an American Society of Anaesthesiologists pre anaesthetic risk assessment (ASA-PS) 3 or less (ASA-PS Classification 1: No organic, biochemical or mental abnormalities. Classification 2: Mild to moderate systematic impairment. Classification 3: severe systematic disorder. Classification 4: Severe systemic disorders that are life-threatening and cannot be cured by surgery. Classification 5: Dying). 4)Persons who give written consent to participate in the study. 5)The diabetic group is defined as those with HbA1c over 6.5% and fasting blood glucose over 126 mg/dl or anytime blood glucose over 200 mg/dl on admission or a clear diagnosis of diabetic retinopathy performed within the last 6 months dating back to the date of surgery.

Exclusion criteria

Exclusion criteria: 1) Patients who do not fulfil the above selection criteria. 2) Patients allergic to amide-type local anaesthetics. 3) Patients on anticoagulant therapy with a PT-INR (Prothrombin Time International Normalised Ratio) > 1.2 or on dual anti-platelet therapy (DAPT), excluding bi-aspirin monotherapy and prophylactic low molecular weight heparin therapy. 4) Patients with contraindications in the package insert. 5) Patients with moderate to severe hepatic dysfunction. 6) Patients with arrhythmic disease requiring pacemaker insertion. 7) Patients who meet all of the "selection criteria" and none of the "exclusion criteria" among the above-mentioned eligible patients are considered as precise criteria. 8) Patients who have refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Ropivacaine blood levels at 15, 30, 45, 60, 90 and 120 min after nerve block.

Secondary

MeasureTime frame
Pain scores (VAS scale: Visual Analogue Scale or NRS: Numerical rating scale) at 0, 2, 6, 12 (pre-sleep and post-awake), 24 and 24 hours post-operatively, number of cases requiring additional rescue analgesia (NSAIDs, weak opioid analgesics) prescribed on the ward post-operatively, and time since surgery. Number of cases requiring additional rescue analgesia (NSAIDs, weak opioid analgesics) on the ward post-operatively and the time since the operation for which the additional analgesia was requested; presence of PONV (post-operative nausea and vomiting); vital signs on leaving the operating theatre (max/min/average blood pressure, respiratory rate, pulse rate); degree of muscle weakness by manual muscle strength test in the lower legs. Time to rehabilitation walking (days). Number of days in hospital. Presence or absence of post-operative delirium. Presence or absence of sleep disturbance.

Countries

Japan

Contacts

Public ContactKeisuke Nakazawa

Nihon University School of Medicine Itabashi Hospital Department of Anesthesiology

nakazawa.keisuke@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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