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Not yet recruitingNCT06395987Updated Dec 5, 2024

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

An observational study in Local Anesthesia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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 .

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Conditions studied

  • Local Anesthesia

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Keywords

  • Wide_awake
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In context

Ankle Fractures

194 studies on the registry are indexed under Ankle Fractures; 46 are open to participants now.

This study's planned enrollment of 60 is below the median of 76 across 36 observational studies indexed under Ankle Fractures.

Browse Ankle Fractures studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The aim of this study is to assess the success of wide-awake local anaesthesia In fixation of ankle fractures.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • ProcedureWide Awake Local Anaesthesia In Fixation Of Ankle Fractures.

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

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What researchers measure

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

    Measure the success rate of wide awake inrelarion to failed cases

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hansen E, Eshelman MR, Cracchiolo A 3rd. Popliteal fossa neural blockade as the sole anesthetic technique for outpatient foot and ankle surgery. Foot Ankle Int. 2000 Jan;21(1):38-44. doi: 10.1177/107110070002100107. PubMed 10710260 ↗
  • Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15. PubMed 25075350 ↗
  • Wright J, MacNeill AL, Mayich DJ. A prospective comparison of wide-awake local anesthesia and general anesthesia for forefoot surgery. Foot Ankle Surg. 2019 Apr;25(2):211-214. doi: 10.1016/j.fas.2017.10.015. Epub 2017 Nov 6. PubMed 29409279 ↗
  • Thomson CJ, Lalonde DH, Denkler KA, Feicht AJ. A critical look at the evidence for and against elective epinephrine use in the finger. Plast Reconstr Surg. 2007 Jan;119(1):260-266. doi: 10.1097/01.prs.0000237039.71227.11. PubMed 17255681 ↗
  • Anderson JG, Bohay DR, Maskill JD, Gadkari KP, Hearty TM, Braaksma W, Padley MA, Weaver KT. Complications After Popliteal Block for Foot and Ankle Surgery. Foot Ankle Int. 2015 Oct;36(10):1138-43. doi: 10.1177/1071100715589741. Epub 2015 Jun 24. PubMed 26109605 ↗
  • Lalonde D. Minimally invasive anesthesia in wide awake hand surgery. Hand Clin. 2014 Feb;30(1):1-6. doi: 10.1016/j.hcl.2013.08.015. Epub 2013 Nov 9. PubMed 24286736 ↗
  • Pires Neto PJ, Moreira LA, Las Casas PP. Is it safe to use local anesthesia with adrenaline in hand surgery? WALANT technique. Rev Bras Ortop. 2017 Jul 19;52(4):383-389. doi: 10.1016/j.rboe.2017.05.006. eCollection 2017 Jun-Jul. PubMed 28884094 ↗
  • Lalonde DH, Wong A. Dosage of local anesthesia in wide awake hand surgery. J Hand Surg Am. 2013 Oct;38(10):2025-8. doi: 10.1016/j.jhsa.2013.07.017. Epub 2013 Sep 8. No abstract available. PubMed 24021739 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06395987
Lead sponsor
Assiut University
Responsible party
Abdallah Sayed Shahata (Assistant Lecturer, Assiut University) — Principal investigator
First posted
May 2, 2024
Start date
Jan 16, 2025 (estimated)
Primary completion
May 16, 2025 (estimated)
Completion
Jul 16, 2025 (estimated)
Last update
Dec 5, 2024

Study contacts

Abdallah Sayed Shahata, resident
Contact
Abdallah.15235623@med.aun.edu.eg
01061205326
Amr Abo-Elfadl Elsayed, Lecturer
Contact
amr.a.mohamed@aun.edu.eg
01007788699
Wael Youssef El-Adly, Professor
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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