To Observe the Clinical Effect of Femoral Nerve Block With Low Concentration of Ropivacaine Based on DPN Grading
1 other identifier
observational
60
1 country
1
Brief Summary
The purpose of this study was to quantitatively standardize the performance of patients with DPN with different course of disease using high-frequency ultrasound, and to design experiments to verify the conclusion that DPN patients with peripheral nerve damage increased nerve sensitivity to local anesthetic drugs and increased block time, and to achieve the same blocking effect by using low-concentration local anesthetic drugs, so as to reduce the probability of complications such as transient nerve injury, severe nerve injury, and local anesthetic poisoning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2024
CompletedFirst Posted
Study publicly available on registry
December 13, 2024
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2025
CompletedAugust 3, 2025
July 1, 2025
Same day
December 10, 2024
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
N/OFQ
Serum N/OFQ levels
24 hours
Secondary Outcomes (2)
Time to onset of nerve block
24 hours
Ratio of femoral nerve to femoral artery cross-sectional area
24 hours
Study Arms (3)
No peripheral vascular neuropathy
Grouping was performed according to the TCSS grading scale
Mild peripheral vascular neuropathy
Grouping was performed according to the TCSS grading scale
Severe peripheral vascular neuropathy
Grouping was performed according to the TCSS grading scale
Interventions
According to the TCSS grading scale, DPN patients were graded into different grades, and the mild and severe groups and the control group were selected to observe the clinical effects between the three groups
Eligibility Criteria
Patients in the Second Hospital of Shanxi Medical University from December 2024 to June 2025
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zheng Guolead
Study Sites (1)
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
yi Han, Doctor
Second Hospital of Shanxi Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
December 10, 2024
First Posted
December 13, 2024
Study Start
August 20, 2025
Primary Completion
August 20, 2025
Study Completion
October 29, 2025
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share