To Observe the Clinical Effect of Femoral Nerve Block With Low Concentration of Ropivacaine Based on DPN Grading

NCT ID: NCT06732362

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2025-10-29

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.

Detailed Description

Clinically, through the correlation study between the serum choliphin concentration and the degree of neuropathy (cross-sectional area) of patients with DPN (scale standardization) of different course of disease and the degree of neuropathy under ultrasound, the DPN was standardized after conclusion, and then the clinical study was designed to use low concentrations of ropivacaine to perform nerve blocks at the same site in patients with DPN of different grades, and the time t of the first use of the analgesic pump after the primary outcome measures, the electrical stimulation threshold during nerve block, and the secondary outcome indicators were the threshold of electrical stimulation during nerve block, Sensory and motor block time-to-occur to assess the effect of nerve block.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

No peripheral vascular neuropathy

Grouping was performed according to the TCSS grading scale

Different DPN ratings

Intervention Type: OTHER

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

Mild peripheral vascular neuropathy

Grouping was performed according to the TCSS grading scale

Different DPN ratings

Intervention Type: OTHER

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

Severe peripheral vascular neuropathy

Grouping was performed according to the TCSS grading scale

Different DPN ratings

Intervention Type: OTHER

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

Interventions

Different DPN ratings

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zheng Guo

OTHER

Sponsor Role: lead

Responsible Party

Zheng Guo

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

yi Han, Doctor

Role: STUDY_DIRECTOR

Second Hospital of Shanxi Medical University

Locations

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Countries

China

Central Contacts

Lingge Tan

Role: CONTACT

13513520761@163.com

13513520761

Other Identifiers

HanYi20241211

Identifier Type: -

Identifier Source: org_study_id