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CompletedNCT05996315Updated Mar 7, 2024

Ultrasound Guided Supracondylar Nerve Block & Hematoma Block for Closed Reduction of Distal End Radius Fractures

An observational study in Adults >18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department, sponsored by Jubilee Mission Medical College and Research Institute. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Jubilee Mission Medical College and Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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 hematoma block or 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. NRS score 2 is assessed once again prior to block and a Hematoma block/ Supracondylar radial nerve block is given. Needle in and out time will be noted and the pain during needling is evaluated using the NRS score 3. Pain score will further be evaluated for every 10 mins after needle out time for a maximum of 30 mins or when the patient gets adequate analgesia ( NRS score 4a, 4b, 4c, 4d).

If the block is successful, the treating physician will proceed to fracture reduction. If the block is a failure the physician will go for a rescue analgesia. NRS score5 will be evaluated at this stage. Further a NRS score 6 will be assessed 15 minutes post reduction. An x-ray will be checked for the evaluation of the reduction procedure performed and the patient will be discharged or admitted as necessary. The patient will be further followed after 1 week for delayed complications.

02

Conditions studied

  • Adults >18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department

Keywords

  • distal end radius fracture
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 40 is below the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient who present with isolated distal end radius fracture.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. History of allergy to local anesthetics
  2. Pregnant or lactating women
  3. Infection or burn with local anaesthetic at injection site
  4. Patients having other fractures or significant injuries that are causing pain
  5. Patients with hemodynamic instability which includes patients with GCS score less than 15 under influence of alcohol/ inebriated state.
  6. Patients on anticoagulants
  7. Patients with compromised neurovascular system
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Adults >18 years with distal end radius fracture

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

    Other: Hematoma block · Other: Supracondylar radial nerve block

Interventions

  • OtherHematoma block

    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.

  • OtherSupracondylar radial nerve block

    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.

06

What researchers measure

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.

    Time frame: 60 minute

Secondary outcomes

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

    To compare the time taken for hematoma block \& supracondylar radial nerve block for closed reduction of distal end radius fracture. Time is noted from needle in to needle out for both technique.

    Time frame: 60minute

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

    compare the analgesic effects of both technique ,which reduces the pain score more during the closed reduction

    Time frame: 60minute

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

    Compare the immediate \& delayed complications upto 7 days after the procedure

    Time frame: 18months

07

Study locations

1 site
  • Emergency Medicine Department of Jubilee Mission Medical College & Research Institute, Thrissur
    Thrissur, Kerala 680 005, India
08

References and documents

Publications

  • 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. PubMed 32843043 ↗
  • 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. PubMed 27342965 ↗
  • 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. PubMed 28920036 ↗
  • 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. PubMed 25016389 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05996315
Lead sponsor
Jubilee Mission Medical College and Research Institute
Responsible party
Dr Roshan Benny (Junior Resident, Jubilee Mission Medical College and Research Institute) — Principal investigator
First posted
Aug 18, 2023
Start date
Sep 15, 2022
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024
Last update
Mar 7, 2024

Oversight

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

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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