Ultrasound guided axillary nerve block compared to hematoma block for analgesia in patients with closed reposition of distal forearm fractures.

Ultrasound guided axillary nerve block compared to hematoma block for analgesia in patients with closed reposition of distal forearm fractures. - USANB trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50895

Enrollment

118

Registered

2021-03-01

Start date

2021-07-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal forearme fracture

Interventions

A patient with a distal forearm fracture who meets the inclusion and exclusion criteria will be randomized and allocated to the FHB or ANB group. The FHB will be performed without ultrasound, as is c

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients in the ED with a X-ray confirmed dislocated distal forearm fracture. Patients >= 16 years of age who are sufficient capable to decise about important medical issues. Patients who have adequate knowledge and understanding of the Dutch language.

Exclusion criteria

Exclusion criteria: Open fractures requiring surgery Multi-trauma patients Inability to give informed consent Abnormal neurovascular examination requiring immediate reposition or surgery Allergy for lidocaine

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is pain reduction on a NRS scale. Pain scores using an 11-step numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable) on different times: o Before application of ANB or FHB. o During the application of ANB or FHB. o During reposition	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints - Total procedural time in minutes from onset of the procedure (FHB or AB) until end of the first reposition. - Complications - Dosage of used anaesthetic - Satisfaction of the physician performing reposition measured on a NRS scale. - Satisfaction of the physician performing the ANB or FHB, measured on a NRS scale. - Patients* satisfactory measured on a NRS scale - Number of attempts for correct injection and positioning Other study parameters - Side of fracture (left/right) - Type of fracture (radius and/or ulna; angulation to volar/dorsal; intra-articular/extra-articular; multi-fragmentary. - Date of trauma (date) - Date of reposition (date) - Age (in years) - Weight (in kg) - Height (in cm) - BMI (underweight 40) - Gender (m/f) - Osteoporosis (yes/no) - Prior fracture of same side (yes/no) - Precise amount and type of local anaesthesia used (mg/kg) - Type and amount of supplementary analgesics (type and dose) - Usage of any pain medication administrated prior for intervention for pain due to fracture (type and dose)	—

Measure

Time frame

Secondary study parameters/endpoints - Total procedural time in minutes from onset of the procedure (FHB or AB) until end of the first reposition. - Complications - Dosage of used anaesthetic - Satisfaction of the physician performing reposition measured on a NRS scale. - Satisfaction of the physician performing the ANB or FHB, measured on a NRS scale. - Patients* satisfactory measured on a NRS scale - Number of attempts for correct injection and positioning Other study parameters - Side of fracture (left/right) - Type of fracture (radius and/or ulna; angulation to volar/dorsal; intra-articular/extra-articular; multi-fragmentary. - Date of trauma (date) - Date of reposition (date) - Age (in years) - Weight (in kg) - Height (in cm) - BMI (underweight 40) - Gender (m/f) - Osteoporosis (yes/no) - Prior fracture of same side (yes/no) - Precise amount and type of local anaesthesia used (mg/kg) - Type and amount of supplementary analgesics (type and dose) - Usage of any pain medication administrated prior for intervention for pain due to fracture (type and dose)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)