Clinical trial NCT05996315: Ultrasound Guided Supracondylar Nerve Block & Hematoma Block for Closed Reduction of Distal End Radius Fractures
Official title: Ultrasound Guided Supracondylar Nerve Block & Hematoma Block for Closed Reduction of Distal End Radius Fractures - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adults >18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department
Keywords: distal end radius fracture
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who present with isolated distal end radius fracture.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 60 minute
Secondary outcomes:
measure: To compare time taken for performing hematoma block & supracondylar radial nerve block
timeFrame: 60minute
measure: To compare time taken for analgesic effect of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture
timeFrame: 60minute
measure: To compare complication rates of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture
timeFrame: 18months
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Emergency Medicine Department of Jubilee Mission Medical College & Research Institute, Thrissur
state: Kerala
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.