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Completed

NCT Number: NCT06381622

Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.

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Key information

Conditions

Nerve Block Anesthesia, Local Brachial Plexus Block Forearm Fracture Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nordsjælland Hospital

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient who have given written informed consent to participate in the study, after having understood it

Inclusion criteria

  • Scheduled for non-acute hand surgery in regional anesthesia
  • Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint

Exclusion criteria

  • BMI > 40 kg/m2
  • Weight < 60 kg
  • Age < 18 years
  • 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 surgery is required

Treatment and study plan

Ropivacaine 0.5% Injectable Solution

Drug

30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine)

Lidocaine Epinephrine

Drug

20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine)

Ropivacaine 0.75% Injectable Solution

Drug

20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine)

Primary outcomes

  1. Total time to breakthrough pain

    Time frame: 24 hours

    From the completion of the LIC block to first sensation of pain from the surgical area.

Secondary outcomes

  1. The onset of sensory block

    Time frame: Until max 45 minutes

    From the completion of the LIC block to complete sensory blockade

    • Tested with refrigerator-cold glass vials.
    • 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 tested nerves obtaining three points on the 3-point scale (no cold sensation).

    This outcome is measured until the complete block is obtained, but no longer than 45 minutes.

    • If a complete sensory block is not obtained after 45 minutes, the LIC block is viewed as a failed block.

  2. Total duration of sensory blockade

    Time frame: 24 hours

    From the completion of the LIC block until the ending of sensory blockade

  3. Total duration of motor blockade

    Time frame: 24 hours

    From the completion of the LIC block until the ending of motor blockade

  4. Degree of motor blockade

    Time frame: At complete sensory blockade and otherwise 45 minutes after block performance

    Measured according to Manual Muscle Testing scale (4 point scale)

    • At the time of complete sensory blockade (defined as all four tested nerves obtaining three points on the 3-point scale (no cold sensation)), or if complete sensory blockade is not obtained, the degree of motor blockade is tested at 45 minutes.
    • Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, movement against resistance is possible, 2 points = a slight difference, movement against slight resistance is possible, 1 point = significant difference, movement is significantly compromised, 0 point = paralysis.

Other outcomes

  1. Pain intensity at pain breakthrough

    Time frame: At pain breakthrough until a maximum of 24 hours after performed block.

    Via Numeric Rating Scale (NRS) 0 - 10 (0 = no pain; 10 = worst pain imaginable)

  2. Duration of maximum pain intensity after the blockade has ended

    Time frame: After the blockade has ended until a maximum of 24 hours after performed block.

    Duration in hours:minutes

  3. Occurence of adverse events (AE) and serious adverse events (SAE)

    Time frame: Follow up after 24 hours and 30 days

    Based on phone interviews and medical records

  4. Failed blockade

    Time frame: Evaluated 30 minutes after completed surgery

    A block is viewed upon as failed if complete sensory block has not been achieved within 45 minutes or if supplemental local anaesthetic is needed before or during surgery.

  5. The patient's experience of the treatment (patient satisfaction)

    Time frame: 24 hours

    Via Numeric Rating Scale (NRS) 0 - 10 (0 = very dissatisfied; 10 = very satisfied)

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

The Effect of Combining Lidocaine and Ropivacaine on the Duration and Onset Time of an Ultrasound-guided Infraclavicular Brachial Plexus Nerve Block. a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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