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

NCT06379490 | Completed Phase 3 DMC

• 3 other identifiers: CTA no: 2024-510572-20-002024-510572-20-00P-2023-296
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Block success

  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.

  45 minutes after block performance

Other Outcomes (17)

• Degree of sensory and motor blockade

  30 to 45 minutes after block performance

• Total duration of sensory blockade

  24 hours after completed block performance

• Total duration of motor blockade

  24 hours after completed block performance

Study Arms (3)

Ropivacaine 5 mg/ml

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0.5% Injectable Solution

Ropivacaine 2 mg/ml

EXPERIMENTAL

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

Drug: Ropivacaine 0.2% Injectable Solution

Lidocaine 10 mg/ml

EXPERIMENTAL

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

Drug: Lidocaine epinephrine

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

30 ml of Ropivacaine 0.2% = 60 mg ropivacaine

Also known as: Ropivacaine 2 mg/ml

Ropivacaine 2 mg/ml

Lidocaine epinephrine DRUG

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

Also known as: Lidocaine 10 mg/ml

Lidocaine 10 mg/ml

Ropivacaine 0.5% Injectable Solution DRUG

30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine

Also known as: Ropivacaine 5 mg/ml

Ropivacaine 5 mg/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Wrist Fractures; Fracture Dislocation; Colles' Fracture

Interventions

Ropivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Radius Fractures

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Anders K. Nørskov, PhD

  Copenhagen University Hospital - North Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: April 23, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)