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

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06732362
• Lead Sponsor: Zheng Guo

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study Start: 2024-12-12
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
N/OFQ	24 hours	Serum N/OFQ levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Second Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China