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

Ultrasound Guided Supracondylar Nerve Block & Hematoma Block for Closed Reduction of Distal End Radius Fractures - an Observational Study

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

Study Overview

• Status: Completed
• Conditions: Adults >18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department
• Intervention / Treatment: Other: Hematoma block; Other: Supracondylar radial nerve block

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient who present with isolated distal end radius fracture.

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other: Supracondylar 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60minute
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	60minute
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	18months

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Ultrasound guided haematoma block may be a safe and effective alternative to procedural sedation and analgesia.
• ultrasound guided radial nerve block is safe

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: distal end radius fracture
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Hemorrhage; Arm Injuries; Forearm Injuries; Emergencies; Fractures, Bone; Radius Fractures; Hematoma
• Other Study ID Numbers: 40/22/IEC/JMMC&RI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No