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ENROLLING BY INVITATION
NCT06395961
NA

Effect of New High Ankle Block on Wound Healing After the Operation of Debridement of Diabetes Foot

Sponsor: Xuzhou Central Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare high ankle block and general anesthesia on wound recovery and ankle blood flow perfusion after diabetes foot surgery in diabetics. The main questions it aims to answer are: * weather the high ankle block can fast wound recovery after the surgery * weather the high ankle block can improve ankle blood flow perfusion after the surgery Participants will receive either high ankle block or general anesthesia during surgery. After the operation, foot ulcer area and pulse perfusion index will be measured on the postoperative day of 1 and 14; lower limb hemodynamic parameters will be measured by ultrasound on the postoperative days of 1, 7, and 14. Researchers will compare high ankle block and general anesthesia to see if they have the different on the wound recovery and blood flow perfusion of the patients' foot.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-08-02

Completion Date

2025-06-15

Last Updated

2024-10-17

Healthy Volunteers

No

Interventions

PROCEDURE

high ankle block

The block position is in the middle and lower third of the calf, about 15cm above the inner or outer ankles. 0.375% ropivacaine is used for the block and the total dose is 35ml. The ultrasound probe is placed vertical to the longitudinal axis of the body. On the lateral of tibia and fibula, 5ml of local anesthetic was injected to block the superficial peroneal nerve and 10ml for the deep peroneal nerve. On the posterior of the calf, 10ml of local anesthetic was injected to block the tibial nerve and 5ml for the sural nerve. On the inner side of the calf, 5ml of local anesthetic was injected to block the saphenous nerve. The "water separation" technique is used and 2ml of physiological saline is injected before blocking to clarify the position of the needle tip and avoid nerve damage. 20 minutes after, the effect was measured using acupuncture by visual analogue scale (VAS) score. If the VAS score is less than 3, the block is considered successful and surgery is immediately performed.

PROCEDURE

general anesthesia

intravenous injection of midazolam 0.03-0.05 mg/kg, etomidate 0.15-0.20 mg/kg, cisatracurium 0.15-0.20 mg/kg, and sufentanil 0.3-0.5 μg/kg. Intraoperative anesthesia maintenance using intravenous infusion of remifentanil 0.1-0.3 μg/kg·min, propofol 4-6 mg/kg·h, maintain bispectral index (BIS) value of 40-60, maintain intraoperative blood pressure and heart rate fluctuations within ± 20% of the baseline value, intermittently inject cisatracurium intravenously as needed. After the surgery, the patient was transferred to post-anaesthesia care unit (PACU). After regaining consciousness and regaining autonomous breathing, the tracheal catheter was removed and transferred to the ward when the indications for transfer were met.

Locations (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China