Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

Phase 3

Completed

• Conditions: Nerve Block; Anesthesia, Local; Brachial Plexus Block; Forearm Fracture; Surgery
• Interventions: Drug: Lidocaine epinephrine; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.75% Injectable Solution

• Registration Number: NCT06381622
• Lead Sponsor: Nordsjaellands Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study Start: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-24
• Primary Completion: 2024-10-24
• Study Completion: 2024-11-23
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group 2: Ropi-7.5+Lido-20	Lidocaine epinephrine	20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine)
Intervention group 2: Ropi-7.5+Lido-20	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)
Control group: Ropi-5	Ropivacaine 0.5% Injectable Solution	30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine)
Intervention group 1: Ropi-5+Lido-20	Ropivacaine 0.5% Injectable Solution	20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
Intervention group 1: Ropi-5+Lido-20	Lidocaine epinephrine	20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)

Primary Outcome Measures

Name	Time	Method
Total time to breakthrough pain	24 hours	From the completion of the LIC block to first sensation of pain from the surgical area.

Secondary Outcome Measures

Name	Time	Method
Total duration of sensory blockade	24 hours	From the completion of the LIC block until the ending of sensory blockade
Total duration of motor blockade	24 hours	From the completion of the LIC block until the ending of motor blockade
The onset of sensory block	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.
Degree of motor blockade	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.

Trial Locations

Locations (1)

Nordsjælland Hospital; 🇩🇰 Hillerød, Denmark