跳至主要内容
临床试验/NCT06395961
NCT06395961Enrolling By Invitation不适用

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

Xuzhou Central Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
70
试验地点
1
主要终点
foot ulcer area

研究概览

简要总结

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.

详细描述

Inclusion criteria: refer to the 2019 World Guide for the Prevention and Treatment of diabetes Feet (DF), DF patients who meet the diagnostic criteria were Wagner's grade 2-4, good communication skills and ability to co-operate in completing various monitoring operations. Exclusion criteria: Skin infection at the puncture site; Concomitant severe cardiovascular and cerebrovascular diseases; Significant abnormalities in coagulation function; Mental abnormalities; Dementia and cognitive impairment. Patients were divided into a high ankle block group (HAB) and a general anesthesia group (GA) using a random number table method.

Regional procedures The patient fasted for 6 hours and stopped drinking for 2 hours before surgery without any preoperative medication. Routine hemodynamic and respiratory monitoring were performed upon entry. In the HAB group, the same senior anesthesiologist performed ultrasound-guided high ankle block on the affected side, with a local anesthetic formula of 0.25% ropivacaine 35ml. The superficial peroneal nerve, deep peroneal nerve, tibial nerve, gastrocnemius nerve, and saphenous nerve were sequentially blocked from one-third of the lower leg to the middle leg (about 15cm above the inner or outer ankle). The method is to place the long axis of the ultrasound probe perpendicular to the longitudinal axis of the body, and place it on the lateral front of the tibia and fibula of the calf. 5ml of local anesthetic is injected to block the superficial peroneal nerve and 10ml to block the deep peroneal nerve; 10ml of local anesthetic is injected to block the tibial nerve behind the calf; 5ml of local anesthetic into the posterior side of the calf to block the sural nerve; 5ml of local anesthetic on the inner side of the calf to block the saphenous nerve. The operation adopts the "water separation" technique, and 2ml of saline is injected before blocking each nerve to clarify the position of the needle tip and avoid nerve damage. 20 minutes after the completion of nerve block surgery, the visual analogue pain score (VAS) was measured using acupuncture, of which the areas innervated are the tibial nerve (posterior ankle and plantar), superficial and deep peroneal nerves (lateral calf and dorsal ankle), sural nerve (lateral calf and ankle), and saphenous nerve (medial calf and ankle). A VAS score of less than 4 indicates successful block, and surgery was performed immediately.

Patients in the GA group did not undergo nerve block and were given anesthesia induction and normal surgery after completing monitoring. Anesthesia induction: 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 a 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 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. Due to the weak postoperative pain stimulation after debridement surgery, neither group received additional postoperative pain pump analgesia. If the patient complained that the VAS score was greater than 4 points, the doctor would provide corresponding medication treatment according to the "three steps" of postoperative pain management.

Measurement of foot ulcer area and pulse perfusion index:

Follow up on the recovery of foot ulcers after surgery, take photos of the patient's ulcer surface using a mobile phone at T0, T7, and T14 time points, and calculate the foot ulcer area using NIH Image J (Version 1.46) software. The pulse oxygen saturation probe of the electrocardiogram monitor collects the T0, T7, and T14 pulse perfusion index (PI) of the first toe of the affected foot.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • refer to the 2019 World Guide for the Prevention and Treatment of diabetes Feet (DF), DF patients who meet the diagnostic criteria were Wagner's grade 2-4, good communication skills and ability to co-operate in completing various monitoring operations.

排除标准

  • Skin infection at the puncture site; Concomitant severe cardiovascular and cerebrovascular diseases; Significant abnormalities in coagulation function; Mental abnormalities; Dementia and cognitive impairment.

结局指标

主要结局

foot ulcer area

时间窗: 1 day before operation, 1 day and 14 days after operation

ulcer area of the diabetes Foot

次要结局

  • pulse perfusion index (PI) of the first toe(1 day before operation, 1 day and 14 days after operation)
  • peak systolic velocity (PSV) of anterior and posterior tibial arteries(1 day before operation, 1 day, 7 days and 14 days after operation)
  • Toe and dorsum skin temperature(1 day before operation, 1 day, 7 days and 14 days after operation)
  • arterial blood flow rate (FV) of anterior and posterior tibial arteries(1 day before operation, 1 day, 7 days and 14 days after operation)
  • time mean velocity (TAmean) of anterior and posterior tibial arteries(1 day before operation, 1 day, 7 days and 14 days after operation)
  • end diastolic velocity (EDV) of anterior and posterior tibial arteries(1 day before operation, 1 day, 7 days and 14 days after operation)

研究者

发起方
Xuzhou Central Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect of New High Ankle Block on Wound Healing... | 临床试验