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

NCT06395961 | Enrolling By Invitation DMC

• 1 other identifier: XuzhouCH-WK1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal; Diabetic Foot Ulcer

Keywords

high ankle block; diabetes foot; wound healing; foot ulcer area; pulse perfusion index; hemodynamic parameters

Outcome Measures

Primary Outcomes (1)

• foot ulcer area

  ulcer area of the diabetes Foot

  1 day before operation, 1 day and 14 days after operation

Secondary Outcomes (6)

• pulse perfusion index (PI) of the first toe

  1 day before operation, 1 day 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

• peak systolic velocity (PSV) 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

• time mean velocity (TAmean) of anterior and posterior tibial arteries

  1 day before operation, 1 day, 7 days and 14 days after operation

Study Arms (2)

HAB group

EXPERIMENTAL

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). 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.

Procedure: high ankle block

GA group

PLACEBO COMPARATOR

No nerve block, only general anesthesia with tracheal intubation.

Procedure: general anesthesia

Interventions

high ankle block PROCEDURE

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.

HAB group

general anesthesia PROCEDURE

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.

GA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Kai Wang, MD

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: May 2, 2024
• Study Start: August 2, 2023
• Primary Completion: May 30, 2025
• Study Completion: June 15, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-05

Locations

CN (1)