Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395987
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-04-29
Brief Title:
Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures
Status:
NOT_YET_RECRUITING
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:
to assess the success of wide-awake local anaesthesia In fixation of ankle fractures
Detailed Description:
The wide-awake local anesthesia with no tourniquet provides an alternative method for the existing anesthesia methods including general anesthesia intrathecal epidural anesthesia peripheral nerve block and local anesthesia with intravenous sedation Each method of them has its inherent risks and costs
The wide-awake local anesthesia has few risks for the patient and can be used in satisfaction where other types of anesthesia particularly general anesthesia are contraindicated
This method is safe effective and provides satisfactory pain and anxiety scores Patients dont have to stay for a long time after surgery It allows the surgery to be done without tourniquet due to the use of epinephrine and this avoids the complication of tourniquet and allows the surgery to be done safely in cases of limb vascular insufficiency and in diabetic patients where tourniquet usage is not favorable
Wide awake local anesthesia method for ankle fracture management is not a novel idea it was previously investigated in one study but the limitation of this study that it was retrospective study with small sample size and without control group treated with other anesthetic modalities
There is concern that the use of lidocaine in hematoma block is harmful for joint cartilage Excess use of epinephrine may cause excessive vasoconstriction and cyanosis of fingers Neuropathic complication are notably high during the early postsurgical period
Wide-awake anesthesia is delivered by the surgeon The role of anesthetic team if needed is monitoring the vital signs and in case of failure of wide-awake and prolonged time of surgery
The wide-awake local anesthesia has few risks for the patient and can be used in satisfaction where other types of anesthesia particularly general anesthesia are contraindicated
This method is safe effective and provides satisfactory pain and anxiety scores Patients dont have to stay for a long time after surgery It allows the surgery to be done without tourniquet due to the use of epinephrine and this avoids the complication of tourniquet and allows the surgery to be done safely in cases of limb vascular insufficiency and in diabetic patients where tourniquet usage is not favorable
Wide awake local anesthesia method for ankle fracture management is not a novel idea it was previously investigated in one study but the limitation of this study that it was retrospective study with small sample size and without control group treated with other anesthetic modalities
There is concern that the use of lidocaine in hematoma block is harmful for joint cartilage Excess use of epinephrine may cause excessive vasoconstriction and cyanosis of fingers Neuropathic complication are notably high during the early postsurgical period
Wide-awake anesthesia is delivered by the surgeon The role of anesthetic team if needed is monitoring the vital signs and in case of failure of wide-awake and prolonged time of surgery
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