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

Completed

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

• Registration Number: NCT05996315
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

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.

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2023-05-20
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-18
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults >18 years with distal end radius fracture	Hematoma block	Adults \> 18 years with distal end radius fracture requiring closed reduction in Emergency Department
Adults >18 years with distal end radius fracture	Supracondylar radial nerve block	Adults \> 18 years with distal end radius fracture requiring closed reduction in Emergency Department

Primary Outcome Measures

Name	Time	Method
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.	60 minute	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.

Secondary Outcome Measures

Name	Time	Method
To compare time taken for performing hematoma block & supracondylar radial nerve block	60minute	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.
To compare complication rates of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture	18months	Compare the immediate \& delayed complications upto 7 days after the procedure
To compare time taken for analgesic effect of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture	60minute	compare the analgesic effects of both technique ,which reduces the pain score more during the closed reduction

Trial Locations

Locations (1)

Emergency Medicine Department of Jubilee Mission Medical College & Research Institute, Thrissur; 🇮🇳 Thrissur, Kerala, India