Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395961
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-02
First Post:
2024-02-27
Brief Title:
Effect of New High Ankle Block on Wound Healing After the Operation of Debridement of Diabetes Foot
Sponsor:
Xuzhou Central Hospital
Organization:
Xuzhou Central Hospital
Study Overview
Official Title:
Effect of New High Ankle Block on Wound Healing After the Operation of Debridement of Diabetes Foot
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 Wagner39s 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 025 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 34water separation34 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 003-005 mgkg etomidate 015-020 mgkg cisatracurium 015-020 mgkg and sufentanil 03-05 μgkg Intraoperative anesthesia maintenance using intravenous infusion of remifentanil 01-03 μgkgmin propofol 4-6 mgkgh 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 34three steps34 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 patient39s ulcer surface using a mobile phone at T0 T7 and T14 time points and calculate the foot ulcer area using NIH Image J Version 146 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
Measurement of arterial blood flow parameters
After the nerve block is completed the patient immediately returns to a supine position with both legs exposed and in an outward rotation position without touching each other Use color Doppler ultrasound take high-frequency linear array probe frequency 10MHz place the probe 3-5 cm above the ankle on the front side of the lower legs look for the anterior tibial artery and the posterior tibial artery first use the color two-dimensional mode to obtain the sagittal axis image of the artery then use the pulse Doppler mode the sampling volume is the size of the inner diameter l3 place the middle of the blood vessel and adjust the Doppler angle the angle between the sound beam and the blood flow direction θ Set at 60 record the arterial blood flow rate FV peak systolic velocity PSV end diastolic velocity EDV time mean velocity TAmean and time maximum mean velocity TAmax using automatic tracking method and mark the position of the probe with a pen The measurement time points were preoperative T0 postoperative day 1 T1 day 7 T7 and day 14 T14
Measurement of skin temperature
Using an infrared thermal imager with a measurement resolution of up to 01 fixed on a lifting frame 30 cm away from the patient39s ankle area skin infrared thermal imaging images were collected and skin temperature was measured The measurement areas were the thumb area dorsum of foot area and anterior tibia area The measurement time points are T0 T1 T7 and T14 respectively During the measurement period instruct the patient not to move their legs
After surgery VAS was used to record the patient39s pain scores on the first day T1 and the second day T2 with scores ranging from 0 to 10 indicating the degree of pain and the use of adjuvant analgesics
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 025 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 34water separation34 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 003-005 mgkg etomidate 015-020 mgkg cisatracurium 015-020 mgkg and sufentanil 03-05 μgkg Intraoperative anesthesia maintenance using intravenous infusion of remifentanil 01-03 μgkgmin propofol 4-6 mgkgh 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 34three steps34 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 patient39s ulcer surface using a mobile phone at T0 T7 and T14 time points and calculate the foot ulcer area using NIH Image J Version 146 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
Measurement of arterial blood flow parameters
After the nerve block is completed the patient immediately returns to a supine position with both legs exposed and in an outward rotation position without touching each other Use color Doppler ultrasound take high-frequency linear array probe frequency 10MHz place the probe 3-5 cm above the ankle on the front side of the lower legs look for the anterior tibial artery and the posterior tibial artery first use the color two-dimensional mode to obtain the sagittal axis image of the artery then use the pulse Doppler mode the sampling volume is the size of the inner diameter l3 place the middle of the blood vessel and adjust the Doppler angle the angle between the sound beam and the blood flow direction θ Set at 60 record the arterial blood flow rate FV peak systolic velocity PSV end diastolic velocity EDV time mean velocity TAmean and time maximum mean velocity TAmax using automatic tracking method and mark the position of the probe with a pen The measurement time points were preoperative T0 postoperative day 1 T1 day 7 T7 and day 14 T14
Measurement of skin temperature
Using an infrared thermal imager with a measurement resolution of up to 01 fixed on a lifting frame 30 cm away from the patient39s ankle area skin infrared thermal imaging images were collected and skin temperature was measured The measurement areas were the thumb area dorsum of foot area and anterior tibia area The measurement time points are T0 T1 T7 and T14 respectively During the measurement period instruct the patient not to move their legs
After surgery VAS was used to record the patient39s pain scores on the first day T1 and the second day T2 with scores ranging from 0 to 10 indicating the degree of pain and the use of adjuvant analgesics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None