Clinical trial NCT06379490: Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures
Official title: Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Distal Radius Fractures
Lidocaine
Ropivacaine
Fracture Dislocation
Closed Reduction of Fracture and Application of Plaster Cast
Colles' Fracture
Keywords: anesthetics, local
regional anesthesia
peripheral nerve block
brachial plexus block
lateral infraclavicular block
closed reduction
distal radius fracture
colles' fracture
wrist fracture
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure.


Eligibility criteria: Inclusion Criteria:

Patients who have given written informed consent to participate in the study after having understood it, as well as:

• Having a distal radius fracture requiring closed reduction

Exclusion Criteria:

Patients who meet one or more of the following criteria will be excluded from participating in the study:

* BMI \> 40 kg/m2
* Weight \< 50 kg
* Age \< 18 years
* American Society of Anesthesiologists (ASA) physical status classification system grade \>3
* Allergy to experimental drugs
* Patients who cannot cooperate with the examinations or treatment
* Patients who do not understand or speak Danish
* Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where closed reduction is required

Primary outcomes:
measure: Block success
timeFrame: 45 minutes after block performance
Secondary outcomes:
Other outcomes:
measure: Degree of sensory and motor blockade
timeFrame: 30 to 45 minutes after block performance
measure: Total duration of sensory blockade
timeFrame: 24 hours after completed block performance
measure: Total duration of motor blockade
timeFrame: 24 hours after completed block performance
measure: Pain intensity before block performance
timeFrame: Up to 45 minutes after inclusion interview
measure: Time to pain relief/lowest pain intensity
timeFrame: Up to 45 minutes after block performance
measure: Pain intensity during closed reduction
timeFrame: Duration of closed reduction (approx. 5 to 10 minutes)
measure: Pain intensity during cast application
timeFrame: Duration of cast application (approx. 5 to 10 minutes)
measure: Time to pain breakthrough after the blockade has ended
timeFrame: Up to 24 hours after block performance
measure: Maximum pain intensity after the blockade has ended
timeFrame: Up to 24 hours after block performance
measure: Duration of maximum pain intensity after the blockade has ended
timeFrame: Up to 24 hours after block performance
measure: Amount of strong painkillers consumed by patients within 24 hours after closed reduction
timeFrame: 24 hours after completed block performance
measure: Grading of closed reduction difficulty
timeFrame: Duration of closed reduction (approx. 5 to 10 minutes)
measure: Quality of closed reduction evaluated by X-ray imaging
timeFrame: 24 hours and 30 days after block performance
measure: Attempts used for closed reduction
timeFrame: Up to 4 hours after block application
measure: Grading of casting difficulty
timeFrame: Duration of cast application (approx. 5 to 10 minutes
measure: The patient's experience of the treatment
timeFrame: Up to 24 hours after block performance
measure: Occurence of adverse events (AE) and serious adverse events (SAE)
timeFrame: 24 hours and 30 days after block performance
Locations:
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand
Study officials:
affiliation: Copenhagen University Hospital - North Zealand
name: Anders K. Nørskov, PhD
role: PRINCIPAL_INVESTIGATOR
References: