NCT06395987

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

April 29, 2024

Last Update Submit

December 4, 2024

Conditions

Local Anesthesia

Keywords

Wide_awake

Outcome Measures

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

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

Interventions

Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures.PROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 10710260BACKGROUND

  • 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.

    PMID: 25075350BACKGROUND

  • 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.

    PMID: 29409279BACKGROUND

  • 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.

    PMID: 17255681BACKGROUND

  • 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.

    PMID: 26109605BACKGROUND

  • 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.

    PMID: 24286736BACKGROUND

  • 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.

    PMID: 28884094BACKGROUND

  • 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.

    PMID: 24021739BACKGROUND

Study Officials

  • Wael Youssef El-Adly, Professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Abdallah Sayed Shahata, resident

CONTACT

01061205326Abdallah.15235623@med.aun.edu.eg

Amr Abo-Elfadl Elsayed, Lecturer

CONTACT

01007788699amr.a.mohamed@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

January 16, 2025

Primary Completion

May 16, 2025

Study Completion

July 16, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12