UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054964 |
|---|---|
| Receipt number | R000062804 |
| Scientific Title | Plasma local anesthetic concentrations after peripheral nerve blockade in diabetic patients. |
| Date of disclosure of the study information | 2024/07/15 |
| Last modified on | 2025/08/07 14:48:00 |
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Basic information
Public title
Relationship between diabetics and local anesthetic concentrations.
Acronym
Diabetes and local anesthetic testing
Scientific Title
Plasma local anesthetic concentrations after peripheral nerve blockade in diabetic patients.
Scientific Title:Acronym
Diabetes and local anesthetic testing
Region
| Japan |
Condition
Condition
Hip joint surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether increased plasma local anaesthetic concentrations after nerve blockade in diabetic patients present different kinetics compared to non-diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ropivacaine blood levels at 15, 30, 45, 60, 90 and 120 min after nerve block.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakazawa |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Department of Anesthesiology
Zip code
173-8610
Address
30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
nakazawa.keisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakazawa |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Department of Anesthesiology
Zip code
173-8610
Address
30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
nakazawa.keisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@nihon-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
RK-230808-5
Org. issuing International ID_1
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation is initiated after completion of general anesthesia.
A single 40ml dose of ropivacaine (3mg per kg) is administered to the fascial surface of iliopsoas muscle using a nerve block needle or epidural needle.
Venous blood samples (1ml to 2ml each) are drawn from an indwelling catheter for measurement of ropivacaine blood levels at 15min, 30min, 45min, 60min, 90min and 120minutes after nerve block.
The serum (plasma) will be deproteinised by organic solvent precipitation using Liquid Chromatograph Mass Spectrometry and quantitatively measured using an internal standard.
Before leaving the room, manual muscle testing of the hip and knee joints is performed.
The patient's pain scale is recorded in the patient's medical record by a doctor or nurse other than the anesthetist in charge of the patient after the operation. The record is made post operatively (2 hours, 6 hours, before going to sleep, the morning after surgery, 24 hours).
The patient's hip and knee joint MMT and cold test to check the recovery of the sensory nerves in the quadriceps muscles are performed post operatively (6 hours, the morning after surgery, 24 hours).
Management information
Registered date
| 2024 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062804
