Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

NCT06381622 | Completed Phase 3 DMC

• 1 other identifier: CTA no: 2023-510028-63-00
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block; Anesthesia, Local; Forearm Fracture; Surgery; Brachial Plexus Block

Keywords

Anesthetics, Local; Lidocaine; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Total time to breakthrough pain

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

  24 hours

Secondary Outcomes (4)

• The onset of sensory block

  Until max 45 minutes

• Total duration of sensory blockade

  24 hours

• Total duration of motor blockade

  24 hours

• Degree of motor blockade

  At complete sensory blockade and otherwise 45 minutes after block performance

Other Outcomes (5)

• Pain intensity at pain breakthrough

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

• Duration of maximum pain intensity after the blockade has ended

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

• Occurence of adverse events (AE) and serious adverse events (SAE)

  Follow up after 24 hours and 30 days

Study Arms (3)

Control group: Ropi-5

ACTIVE COMPARATOR

30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine)

Drug: Ropivacaine 0.5% Injectable Solution

Intervention group 1: Ropi-5+Lido-20

EXPERIMENTAL

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; Drug: Lidocaine epinephrine

Intervention group 2: Ropi-7.5+Lido-20

EXPERIMENTAL

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; Drug: Ropivacaine 0.75% Injectable Solution

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

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

Control group: Ropi-5; Intervention group 1: Ropi-5+Lido-20

Lidocaine epinephrine DRUG

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; Intervention group 2: Ropi-7.5+Lido-20

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)

Intervention group 2: Ropi-7.5+Lido-20

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjælland Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Yousef S, Steensbaek MT, Bahuet AR, Knudsen RL, Harwood CD, Rosenstock CV, Andersen MF, Rothe C, Lange KHW, Norskov AK, Lundstrom LH. The effect of combining lidocaine and ropivacaine on the duration and onset time of an ultrasound-guided infraclavicular brachial plexus nerve block: A randomised controlled trial. Eur J Anaesthesiol. 2025 Dec 1;42(12):1046-1055. doi: 10.1097/EJA.0000000000002261. Epub 2025 Sep 1.

  PMID: 40859881 DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christian Rothe, PhD

  Nordsjællands Hospital, Københavns Universitet, Hillerød

  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 12, 2024
• First Posted: April 24, 2024
• Study Start: April 18, 2024
• Primary Completion: October 24, 2024
• Study Completion: November 23, 2024
• Last Updated: February 17, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)