Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2025-06-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Distal Radius Fractures Lidocaine Ropivacaine Fracture Dislocation Closed Reduction of Fracture and Application of Plaster Cast Colles' Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine 5 mg/ml

30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once)

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine

Ropivacaine 2 mg/ml

30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once)

Group Type EXPERIMENTAL

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

30 ml of Ropivacaine 0.2% = 60 mg ropivacaine

Lidocaine 10 mg/ml

30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once)

Group Type EXPERIMENTAL

Lidocaine epinephrine

Intervention Type DRUG

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

Interventions

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Ropivacaine 0.2% Injectable Solution

30 ml of Ropivacaine 0.2% = 60 mg ropivacaine

Intervention Type DRUG

Lidocaine epinephrine

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

Intervention Type DRUG

Ropivacaine 0.5% Injectable Solution

30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine

Intervention Type DRUG

Other Intervention Names

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Ropivacaine 2 mg/ml Lidocaine 10 mg/ml Ropivacaine 5 mg/ml

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No