To Observe the Clinical Effect of Femoral Nerve Block With Low Concentration of Ropivacaine Based on DPN Grading
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Different DPN ratings.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 55 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
To Observe the Clinical Effect of Femoral Nerve Block With Low Concentration Ropivacaine Under Ultrasound Guidance Combined With Neurostimulator Based on DPN Grading
Overview
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.
Interventions
- 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
Primary outcome measures
- N/OFQ [Time frame: 24 hours]
Secondary outcome measures (2)
- Time to onset of nerve block [Time frame: 24 hours]
- Ratio of femoral nerve to femoral artery cross-sectional area [Time frame: 24 hours]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Second Hospital of Shanxi Medical University — Taiyuan
Identifiers
NCT: NCT06732362 · HanYi20241211