Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Surgery; Brachial Plexus Block; Nerve Block; Forearm Fracture
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Lidocaine epinephrine; Drug: Ropivacaine 0.75% Injectable Solution

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjælland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group: Ropi-5; 30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine)	Drug: Ropivacaine 0.5% Injectable Solution; 30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine)
Experimental: Intervention group 1: Ropi-5+Lido-20; 20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)	Drug: Ropivacaine 0.5% Injectable Solution; 30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine); Drug: Lidocaine epinephrine; 20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
Experimental: Intervention group 2: Ropi-7.5+Lido-20; 20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine)	Drug: Lidocaine epinephrine; 20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine); Drug: Ropivacaine 0.75% Injectable Solution; 20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time to breakthrough pain	From the completion of the LIC block to first sensation of pain from the surgical area.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The onset of sensory block	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.	Until max 45 minutes
Total duration of sensory blockade	From the completion of the LIC block until the ending of sensory blockade	24 hours
Total duration of motor blockade	From the completion of the LIC block until the ending of motor blockade	24 hours
Degree of motor blockade	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.	At complete sensory blockade and otherwise 45 minutes after block performance

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at pain breakthrough	Via Numeric Rating Scale (NRS) 0 - 10 (0 = no pain; 10 = worst pain imaginable)	At pain breakthrough until a maximum of 24 hours after performed block.
Duration of maximum pain intensity after the blockade has ended	Duration in hours:minutes	After the blockade has ended until a maximum of 24 hours after performed block.
Occurence of adverse events (AE) and serious adverse events (SAE)	Based on phone interviews and medical records	Follow up after 24 hours and 30 days
Failed blockade	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.	Evaluated 30 minutes after completed surgery
The patient's experience of the treatment (patient satisfaction)	Via Numeric Rating Scale (NRS) 0 - 10 (0 = very dissatisfied; 10 = very satisfied)	24 hours

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Christian Rothe, PhD, Nordsjællands Hospital, Københavns Universitet, Hillerød

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): November 23, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Lidocaine; Ropivacaine; Anesthetics, Local
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Lidocaine; Pharmaceutical Solutions; Epinephrine
• Other Study ID Numbers: CTA no: 2023-510028-63-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No