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NCT Number: NCT06732362

To Observe the Clinical Effect of Femoral Nerve Block With Low Concentration of Ropivacaine 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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Different DPN ratings

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

Primary outcomes

  1. N/OFQ

    Time frame: 24 hours

    Serum N/OFQ levels

Secondary outcomes

  1. Time to onset of nerve block

    Time frame: 24 hours

    The sensorimotor disappearance time was observed after self-administration

  2. Ratio of femoral nerve to femoral artery cross-sectional area

    Time frame: 24 hours

    The ratio of the two was measured to observe the change

Study contacts

Contact information is provided by the study sponsor or research team.

Lingge Tan

CONTACT

[email protected]

13513520761

Sponsors and collaborators

Lead sponsor

Zheng Guo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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