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

Z

Zheng Guo

Status

Not yet enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Different DPN ratings

Study type

Observational

Funder types

Other

Identifiers

NCT06732362
HanYi20241211

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

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.

Trial design

60 participants in 3 patient groups

No peripheral vascular neuropathy
Description:
Grouping was performed according to the TCSS grading scale
Treatment:
Other: Different DPN ratings
Mild peripheral vascular neuropathy
Description:
Grouping was performed according to the TCSS grading scale
Treatment:
Other: Different DPN ratings
Severe peripheral vascular neuropathy
Description:
Grouping was performed according to the TCSS grading scale
Treatment:
Other: Different DPN ratings

Trial contacts and locations

1

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Central trial contact

Lingge Tan

Data sourced from clinicaltrials.gov

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