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

To Observe the Clinical Effect of Femoral Nerve Block With Low Concentration Ropivacaine Under Ultrasound Guidance Combined With Neurostimulator Based on DPN Grading

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Different DPN ratings

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Lingge Tan; Phone Number: 13513520761; Email: 13513520761@163.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients in the Second Hospital of Shanxi Medical University from December 2024 to June 2025

Description

Inclusion Criteria:All patients met the 1999 WHO diagnostic criteria for diabetes.

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Exclusion Criteria:(1) Type 1 diabetes; (2) Peripheral neuropathy obviously caused by other reasons; (3) Patients with neuropathy caused by diabetic foot ulcers and gangrene, as well as known history of bone and joint trauma or surgery of the lower limbs; (4) Contraindications to peripheral nerve block (such as local anesthetic allergy, coagulation dysfunction, peripheral infection, etc.) (5) Contraindications to drug components of postoperative analgesic pumps; (6) Existing opioid therapy.

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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No peripheral vascular neuropathy; Grouping was performed according to the TCSS grading scale	Other: 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
Mild peripheral vascular neuropathy; Grouping was performed according to the TCSS grading scale	Other: 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
Severe peripheral vascular neuropathy; Grouping was performed according to the TCSS grading scale	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N/OFQ	Serum N/OFQ levels	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of nerve block	The sensorimotor disappearance time was observed after self-administration	24 hours
Ratio of femoral nerve to femoral artery cross-sectional area	The ratio of the two was measured to observe the change	24 hours

Collaborators and Investigators

• Sponsor: Zheng Guo
• Investigators: Study Director: yi Han, Doctor, Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2025
• Primary Completion (Estimated): August 20, 2025
• Study Completion (Estimated): October 29, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HanYi20241211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No