Clinical trial • Not applicable • Musculoskeletal|Other

epinephrine, lidocaine hydrochloride for Distal radius fracture

Not applicable trial of epinephrine, lidocaine hydrochloride for Distal radius fracture.

Overview

Trial Therapeutic Area
Musculoskeletal|Other
Trial Disease
Distal radius fracture
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-06-2024
First CTIS Authorization Date
12-09-2024

Trial design

Randomised, two arms: 1) ultrasound-guided brachial plexus nerve block using lidokain-adrenalin (epinephrine and lidocaine hydrochloride) solution, perineural administration (product: lidokain-adrenalin sad, injektionsvæske, opløsning). dose details not specified in protocol documents beyond smpc information (product records list dose unit mg/kg and max total dose 7 mg/kg). 2) haematoma block (standard care).-controlled Not applicable trial across 12 sites in Denmark.

Randomised
Yes
Comparator
Two arms: 1) Ultrasound-guided brachial plexus nerve block using Lidokain-adrenalin (epinephrine and lidocaine hydrochloride) solution, perineural administration (product: Lidokain-adrenalin SAD, injektionsvæske, opløsning). Dose details not specified in protocol documents beyond SmPC information (product records list dose unit mg/kg and max total dose 7 mg/kg). 2) Haematoma block (standard care).
Target Sample Size
1716
Trial Duration For Participant
90

Eligibility

Recruits 1716 Vulnerable population not selected. Only adults (age ≥ 18 years) are eligible. Informed consent is required ("Lack of informed consent" is an exclusion criterion). No assent process or other vulnerable-population consent arrangements are described..

Vulnerable Population
Vulnerable population not selected. Only adults (age ≥ 18 years) are eligible. Informed consent is required ("Lack of informed consent" is an exclusion criterion). No assent process or other vulnerable-population consent arrangements are described.

Inclusion criteria

  • {"criterion_text":"- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction"}

Exclusion criteria

  • {"criterion_text":"- Patients who would never qualify for surgery according to local guidelines"}
  • {"criterion_text":"- Lack of informed consent"}
  • {"criterion_text":"- No Danish Central Person Register (CPR) number"}
  • {"criterion_text":"- Allergies to the trial medication"}
  • {"criterion_text":"- Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction"}
  • {"criterion_text":"- Open fracture (fracture-related wound requiring sutures), other fractures on the same extremity (NOT including distal ulna fracture(s)) or bilateral distal radius fractures both requiring closed reduction."}
  • {"criterion_text":"- Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Cumulative proportion of patients with distal radius fracture surgery 90 days after closed reduction","definition_or_measurement_approach":"Measured as the cumulative proportion of participants undergoing distal radius fracture surgery within 90 days after the closed reduction procedure."}

Secondary endpoints

  • {"endpoint_text":"- Composite outcome of treatment related complications: loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment, pneumothorax, allergic reaction, new bone or joint injury after the closed reduction and/or pulmonary embolism witin 90 days after closed reducti","definition_or_measurement_approach":"Composite of specified treatment-related complications occurring within 90 days after closed reduction (as listed)."}
  • {"endpoint_text":"- Patient Rated Wrist Evaluation (PRWE) 90 days after closed reduction","definition_or_measurement_approach":"PRWE score assessed at 90 days after closed reduction."}
  • {"endpoint_text":"- Maximum pain score (Numerical Rating Scale (NRS) 0-10) in the affected wrist during closed reduction(s)","definition_or_measurement_approach":"Maximum NRS (0-10) pain score recorded in the affected wrist during closed reduction procedure(s)."}
  • {"endpoint_text":"- Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction, according to AAOS guidelines","definition_or_measurement_approach":"Proportion determined by assessing immediate post-reduction radiographs against AAOS guidelines criteria for unacceptable fracture position."}

Recruitment

Planned Sample Size
1716
Recruitment Window Months
29
Consent Approach
Informed consent is required from each participant; lack of informed consent is an exclusion. Only adults (≥18 years) are eligible. Subject information and informed consent forms are available in Danish and English (multiple document versions present). No assent process described.

Geography

Total Number Of Sites
12
Total Number Of Participants
1716

Denmark

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
458
Number Of Sites
12
Number Of Participants
1716

Sites

Site Name
Region Midtjylland
Department Name
Department of Operation and Intensive Care
Contact Person Name
Jeppe Henriksen
Contact Person Email
jephen@rm.dk
Site Name
Slagelse Hospital
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Jesper Kent Nielsen
Contact Person Email
jken@regionsjaelland.dk
Site Name
Holbaek Sygehus
Department Name
Department of Emergency Medicine
Contact Person Name
Jógvan Olivar Matras
Contact Person Email
jogm@regionsjaelland.dk
Site Name
Hvidovre Hospital
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Rune Sort
Contact Person Email
rune.sort.01@regionh.dk
Site Name
Region Midtjylland
Department Name
Department of Emergency Medicine
Contact Person Name
Malik Kalmriz
Contact Person Email
alik@aarhus.rm.dk
Site Name
Region Hovedstaden
Department Name
Dept. of Orthopedic Surgery
Contact Person Name
Pelle Baggesgaard Petersen
Site Name
Lillebaelt Hospital
Department Name
Department of Anaesthesiology
Contact Person Name
Morten Rune Blichfeldt-Eckhardt
Contact Person Email
mr.be@rsyd.dk
Site Name
Region Midtjylland
Department Name
Department of Orthopaedic
Contact Person Name
Per Hviid Guntofte
Contact Person Email
pergun@rm.dk
Site Name
Zealand University Hospital
Department Name
Department of Orthopaedic Surgery
Contact Person Name
Danny Yu
Contact Person Email
dy@regionsjaelland.dk
Site Name
Odense University Hospital
Department Name
Department of Orthopaedic Surgery
Contact Person Name
Joakim Jensen
Contact Person Email
Joakim.jensen@rsyd.dk
Site Name
Copenhagen University Hospital
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Troels Haxholdt Lunn
Contact Person Email
lunn@dadlnet.dk
Site Name
Hillerod Hospital
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Anders Kehlet Nørskov

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Lidokain-adrenalin SAD, injektionsvæske, opløsning
Active Substance
epinephrine, lidocaine hydrochloride
Modality
Small molecule
Routes Of Administration
Perineural use
Route
Perineural
Authorisation Status
Marketing-authorised in Denmark (marketingAuthNumber 16318)
Maximum Dose
7 mg/kg (max total dose)
Combination Treatment
Yes

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