NCT05996315

Brief Summary

Comparison of analgesia between ultrasound guided supracondylar radial nerve block and hematoma block for closed reduction of distal end radius fractures- an observational study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

May 20, 2023

Last Update Submit

March 6, 2024

Conditions

Keywords

distal end radius fracture

Outcome Measures

Primary Outcomes (1)

  • To compare analgesic effect of supracondylar radial nerve block with hematoma block under ultrasound guidance in closed reduction of distal end radius fractures in emergency department assessed using numerical rating scale.

    To assess the difference in analgesic effect of supracondylar radial nerve block with hematoma block under ultrasound guidance in closed reduction of distal end radius fractures in emergency department assessed using numerical rating scale.

    60 minute

Secondary Outcomes (3)

  • To compare time taken for performing hematoma block & supracondylar radial nerve block

    60minute

  • To compare time taken for analgesic effect of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture

    60minute

  • To compare complication rates of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture

    18months

Study Arms (1)

Adults >18 years with distal end radius fracture

Adults \> 18 years with distal end radius fracture requiring closed reduction in Emergency Department

Other: Hematoma blockOther: Supracondylar radial nerve block

Interventions

A patient who presents to the emergency department with a suspected distal end radius fracture , will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give hematoma block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase.

Adults >18 years with distal end radius fracture

A patient who presents to the emergency department with a suspected distal end radius fracture will be assessed with a baseline NRS score1 and given analgesics if needed. Further they will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give supracondylar radial nerve block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase.

Adults >18 years with distal end radius fracture

Eligibility Criteria

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

Patient who present with isolated distal end radius fracture.

You may qualify if:

  • Adults \> 18 years with distal end radius fracture requiring closed reduction in Emergency Department
  • Patient who legally consent for study

You may not qualify if:

  • History of allergy to local anesthetics
  • Pregnant or lactating women
  • Infection or burn with local anaesthetic at injection site
  • Patients having other fractures or significant injuries that are causing pain
  • Patients with hemodynamic instability which includes patients with GCS score less than 15 under influence of alcohol/ inebriated state.
  • Patients on anticoagulants
  • Patients with compromised neurovascular system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medicine Department of Jubilee Mission Medical College & Research Institute, Thrissur

Thrissur, Kerala, 680 005, India

Location

Related Publications (4)

  • Maleitzke T, Plachel F, Fleckenstein FN, Wichlas F, Tsitsilonis S. Haematoma block: a safe method for pre-surgical reduction of distal radius fractures. J Orthop Surg Res. 2020 Aug 26;15(1):351. doi: 10.1186/s13018-020-01819-y.

    PMID: 32843043BACKGROUND
  • Unluer EE, Karagoz A, Unluer S, Kosargelir M, Kizilkaya M, Alimoglu O, Akoglu H, Aslan C. Ultrasound-guided supracondylar radial nerve block for Colles Fractures in the ED. Am J Emerg Med. 2016 Aug;34(8):1718-20. doi: 10.1016/j.ajem.2016.06.007. Epub 2016 Jun 8. No abstract available.

    PMID: 27342965BACKGROUND
  • Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb.

    PMID: 28920036BACKGROUND
  • Fathi M, Moezzi M, Abbasi S, Farsi D, Zare MA, Hafezimoghadam P. Ultrasound-guided hematoma block in distal radial fracture reduction: a randomised clinical trial. Emerg Med J. 2015 Jun;32(6):474-7. doi: 10.1136/emermed-2013-202485. Epub 2014 Jul 12.

    PMID: 25016389BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident

Study Record Dates

First Submitted

May 20, 2023

First Posted

August 18, 2023

Study Start

September 15, 2022

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations