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Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures

Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06395987
Enrollment
60
Registered
2024-05-02
Start date
2025-01-16
Completion date
2025-07-16
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

Wide_awake

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 don't 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 .

Interventions

PROCEDUREWide Awake Local Anaesthesia In Fixation Of Ankle Fractures.

Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All adult patients with unstable ankle fracture who need fixation presenting to the Trauma Unit of Assiut University Hospital with the following criteria: 1. Age ≥ 18 years. 2. Isolated ankle fracture in one or both lower limbs.

Exclusion criteria

1. patients\< 18 years. 2. Patients with uncontrolled diabetes mellitus. 3. open fractures. 4. Associated fractures in the lower limbs(Spinal anaesthesia will be more suitable in multiple fractures) 5. Fractures managed by closed contact casting. 6. Patients with dementia and psychological disease.

Design outcomes

Primary

MeasureTime frameDescription
• Success of wide-awake local anaesthesia in fixation of ankle fractures by measuring the amount of failure of wide awake local anesthesiaFollow up for 6 months to assess if there is any complications .Measure the success rate of wide awake inrelarion to failed cases

Contacts

Primary ContactAbdallah Sayed Shahata, resident
Abdallah.15235623@med.aun.edu.eg01061205326
Backup ContactAmr Abo-Elfadl Elsayed, Lecturer
amr.a.mohamed@aun.edu.eg01007788699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026