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

Not yet recruiting

• Conditions: Local Anesthesia

• Registration Number: NCT06395987
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Study Start: 2025-01-16
• Primary Completion: 2025-05-16
• Study Completion: 2025-07-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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