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

Phase 3

Recruiting

• Conditions: Ropivacaine; Fracture Dislocation; Closed Reduction of Fracture and Application of Plaster Cast; Colles' Fracture; Lidocaine; Distal Radius Fractures
• Interventions: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Lidocaine epinephrine; Drug: Ropivacaine 0.2% Injectable Solution

• Registration Number: NCT06379490
• Lead Sponsor: Nordsjaellands Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study Start: 2024-04-23
• Study First Posted: 2024-04-23
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 5 mg/ml	Ropivacaine 0.5% Injectable Solution	30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once)
Lidocaine 10 mg/ml	Lidocaine epinephrine	30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once)
Ropivacaine 2 mg/ml	Ropivacaine 0.2% Injectable Solution	30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once)

Primary Outcome Measures

Name	Time	Method
Block success	45 minutes after block performance	The incidence of successful blockade 45 minutes after block performance.; The following 4 nerves will be tested: radial, musculocutaneous, ulnar and median nerves.; Sensory blockade assessment: * A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.; * A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation).; Motor blockade assessment: * Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, the movement against resistance is possible, 2 points = a slight difference, the movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 points = paralysis.; * A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points.; Successful blockade: • Complete sensory and motor blockade 45 minutes after block performance.

Trial Locations

Locations (1)

Copenhagen University Hospital - North Zealand; 🇩🇰 Hillerød, Denmark