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NCT Number: NCT06395987

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

to assess the success of wide-awake local anaesthesia In fixation of ankle fractures

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • Age ≥ 18 years.
  • Isolated ankle fracture in one or both lower limbs.

Exclusion criteria

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

Treatment and study plan

Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures.

Procedure

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

Primary outcomes

  1. • Success of wide-awake local anaesthesia in fixation of ankle fractures by measuring the amount of failure of wide awake local anesthesia

    Time frame: Follow up for 6 months to assess if there is any complications .

    Measure the success rate of wide awake inrelarion to failed cases

Study contacts

Contact information is provided by the study sponsor or research team.

Abdallah Sayed Shahata, resident

CONTACT

[email protected]

01061205326

Amr Abo-Elfadl Elsayed, Lecturer

CONTACT

[email protected]

01007788699

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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