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

Sponsor
Jubilee Mission Medical College and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05996315
Collaborator
(none)
40
1
17
2.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultrasound Guided Supracondylar Nerve Block & Hematoma Block for Closed Reduction of Distal End Radius Fractures - an Observational Study
Actual Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  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. [60 minute]

    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 during before closed reduction, during reduction & after closed reduction.

Secondary Outcome Measures

  1. 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.

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emergency Medicine Department of Jubilee Mission Medical College & Research Institute, Thrissur Thrissur Kerala India 680 005

Sponsors and Collaborators

  • Jubilee Mission Medical College and Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Dr Roshan Benny, Junior Resident, Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier:
NCT05996315
Other Study ID Numbers:
  • 40/22/IEC/JMMC&RI
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Roshan Benny, Junior Resident, Jubilee Mission Medical College and Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023