Clinical trial

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

Name

CTA no: 2024-510572-20-00

Description

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.

Trial arms

Trial start

2024-04-23

Estimated PCD

2024-08-01

Trial end

2025-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Ropivacaine 0.2% Injectable Solution

30 ml of Ropivacaine 0.2% = 60 mg ropivacaine

Arms:

Ropivacaine 2 mg/ml

Other names:

Ropivacaine 2 mg/ml

Lidocaine epinephrine

30 ml of Lidocaine 1% with 5 μg/ml epinephrine = 300 mg lidocaine + 150 μg epinephrine

Arms:

Lidocaine 10 mg/ml

Other names:

Lidocaine 10 mg/ml

Ropivacaine 0.5% Injectable Solution

30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine

Arms:

Ropivacaine 5 mg/ml

Other names:

Ropivacaine 5 mg/ml

Size

Primary endpoint

Block success

45 minutes after block performance

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 63, 'type': 'ESTIMATED'}}

Updated at

2024-04-24

1 organization

2 products

6 indications

Organization

Nordsjaellands Hospital

Product

Ropivacaine

Indication

Wrist Fractures

Indication