CompletedNot Applicable

Efficacy and Safety of Hematoma Block Versus Brachial Plexus Block for Closed Reduction of Extra-Articular Distal Radius Fracture: A Prospective Study

Nepal90 participantsStarted 2024-01-20

Plain-language summary

Distal radius fractures are one of the most common types of fractures, affecting mostly youngsters and the elderly. Safety, ease of use, affordability, and effectiveness all play a role in analgesia during reduction. This study's goal is to assess how well the Hematoma Block (HB) reduces distal forearm fractures in a developing nation like Nepal. At a tertiary care hospital, a randomized comparative study is used. The individuals with distal forearm fractures that have been radiologically confirmed are enrolled after taking informed consent. When reducing distal forearm fractures, the patients are divided into two groups: Brachial Plexus Block (BPB group) and Hematoma Block group. We note the level of pain before, during, and after reduction using the Visual Analogue Scale (VAS) in both groups. The patient's radiological correction is assessed by Modified Sarmiento Criteria with an immediate post reduction radiograph. Comparing Hematoma Block and Brachial Plexus Block, we can choose a definitive easy method for reduction that is easy, safe and less time consuming. Hence, the study will provide a guide for commonly occurring distal radius fracture. Hypotheses of the Study: Null hypothesis (Ho): There is no difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques. Ho: Safety, efficacy and quality of reduction with Hematoma block = Brachial plexus block Alternate hypothesis (H1): There is a difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques. H1: Safety, efficacy and quality of reduction with Hematoma block ≠ Brachial plexus block

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult male or female patients in the age range of skeletally mature (18 years and above)
. Displaced distal radius fracture, requiring manipulation
. Only extra-articular fractures.

Exclusion criteria

. Open fractures (Gustilo Anderson open fracture Type I, II and III), intra-articular fractures, and comminuted fractures.
. Undisplaced distal radial fractures which do not require manipulation.
. Patients who have a history of an adverse reaction to local anesthetics.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Severity Assessed by Visual Analogue Scale (VAS)

Timeframe: 1 year

Quality of Fracture Reduction Assessed by Plain Radiographic Parameters

Timeframe: 1 year

Trial details

NCT IDNCT07625787

SponsorKathmandu University School of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

View on ClinicalTrials.gov More Distal Radius Fracture trials