Ultrasound Guided Hematoma Block in Distal Radius Fractures

Ultrasound Guided Hematoma Block vs. Blind Hematoma Block in Distal Radius Fractures, a Randomized Controlled Trial

This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.

Study Overview

• Status: Recruiting
• Conditions: Fracture Dislocation; Distal Radius Fractures; Dislocated Wrist; Dislocated Radius
• Intervention / Treatment: Device: Ultrasound guided hematoma block.; Procedure: Blind hematoma block

Detailed Description

Distal radius fractures represent one of the most common injuries in the Emergency Department (ED). Proper treatment especially for dislocated fractures can minimize the chance of residual injury. For closed reduction anesthesia is essential for safety, satisfaction and result. Different methods of regional anesthesia can be used but hematoma block (HB) is the technique most often used in EDs in the Netherlands and recommended by Dutch guidelines. In practice however a HB, does not always lead to adequate anesthesia, this might be because of poor infiltration into the fracture site. Ultrasound could additionally provide real-time guidance of injection into the fracture site, maximizing the analgesic effect of HB. In this study the effectiveness of analgesia of ultrasound HB will be compared to 'blind' HB in patients with a dislocated distal radius fracture.

Patients with a confirmed dislocated fracture of the distal radius requiring closed reduction will be randomized to either ultrasound guided hematoma block or normal 'blind' hematoma block. NRS-scores will be given before, during and after hematoma block and during and after reduction of the fracture. These scores will be the primary endpoint of this study.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pieter Veenstra; Phone Number: (058) 286 3852; Email: pieter.veenstra@mcl.nl
• Study Contact Backup: Name: Heleen Lameijer; Phone Number: (058) 286 3112; Email: heleen.lameijer@mcl.nl

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934AD
      • Recruiting
      • Medisch Centrum Leeuwarden
      • Contact: Pieter Veenstra; Email: pieter.veenstra@mcl.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 16 years

• Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):

  • >10 degrees of dorsal angulation;
  • >20 degrees of volar angulation;
  • >2 mm step-off intra-articular;
  • >3 mm radial shortening;
  • >15 degrees radial inclination;
  • Translation and non-intact radio-carpal alignment in the lateral view
  • Significant translation in the posterior-anterior(PA)-view.

Exclusion Criteria:

• No informed consent can be given (cognitive impairment, severe dementia, no knowledge of Dutch language e.a.)
• Neurovascular compromise or open fractures requiring (immediate) surgery or reduction.
• First reduction already performed
• Multi-trauma patients requiring other urgent procedures/tests or with respiratory or hemodynamical compromise
• Pre-existent osteosynthesis material in situ in the affected arm
• Skin injury (with exception of minor abrasions), local infection or recent burns hindering or contra-indicating the use of ultrasound and ultrasound gel
• Allergy for local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound guided hematoma block; Patients in this group will receive ultrasound guided hematoma block before reduction of their dislocated distal radius fracture.	Device: Ultrasound guided hematoma block.; Patients with a dislocated fracture of the distal radius will receive ultrasound guided hematoma block with 10mL lidocaine 2% to get real-time guidance of the given anesthesia into the fracture site before closed reduction of a distal radius fracture.
Active Comparator: Blind hematoma block; Patients in this group will receive standard treatment; hematoma block with palpation of the fracture site (blind hematoma block)	Procedure: Blind hematoma block; Patients with a distal radius fracture will receive standard treatment; hematoma block with 10mL 2% lidocaine performed with palpation of the fracture site (blind hematoma block) before closed reduction of dislocated distal radius fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of analgesia during closed reduction of a distal radius fracture	Pain reduction will be measured on a Numeric Rating Scale( NRS-scale; 0-10) at different moments	NRS before, during and after (10-15 min) injection of hematoma block, NRS-score during closed reduction and after closed reduction (5 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of the patient for procedure and reduction	measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied)	10-15 minutes after closed reduction
Years of experience of treating physician in performing HB.	Years of experience of treating physician in performing HB.	(up to) 10-15 minutes after last closed reduction attempt
Years of experience of treating physician with use of ultrasound.	Years of experience of treating physician with use of ultrasound.	(up to) 10-15 minutes after last closed reduction attempt
Number of participants in which hematoma was aspirated during hematoma block	Measure of correct position of hematoma block if there is aspiration of blood (yes/no)	During hematoma block
Procedural time of the Hematoma block	Time needed to perform HB (blind or ultrasound-guided; from moment of localization of the fracture until the moment the needle is out of the patient)	Time from insertion of the needle until needle is withdrawn out of the patient (up to maximum of 30 min.)
Procedural time of the reduction	Time needed to perform reduction of the fracture	From moment physician is ready to start the reduction until cast is applied (up to maximum of 30 min.)
Satisfaction of the HB provided by physician performing the HB procedure	measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied)	10-15 minutes after hematoma block
Satisfaction of reduction provided by physician performing reduction measured	measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied)	10-15 minutes after closed reduction
Satisfaction of the nurse for procedure and reduction	measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied)	10-15 minutes after closed reduction
Number of reductions	Defined as attempt(s) to align fracture and application of cast	(up to) 10-15 minutes after last closed reduction attempt
Number of patients in which palpation of an evident step-off near fracture site was felt	Before performing hematoma block performing physician will palpate if there is a clear step-off near the fracture site (important especially in blind hematoma group)	During performing hematoma block

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: Pieter Veenstra, Medisch Centrum Leeuwarden

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Distal radius fracture; Hematoma block
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Joint Diseases; Musculoskeletal Diseases; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Joint Dislocations; Radius Fractures; Hematoma; Fracture Dislocation; Wrist Fractures
• Other Study ID Numbers: 20230041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No