Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-18

Study Completion Date

2024-11-23

Brief Summary

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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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Detailed Description

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Conditions

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Nerve Block Anesthesia, Local Forearm Fracture Surgery Brachial Plexus Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group: Ropi-5

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

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

Lidocaine epinephrine

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Lidocaine epinephrine

Intervention Type 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

Intervention Type DRUG

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

Interventions

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Ropivacaine 0.5% Injectable Solution

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

Intervention Type DRUG

Lidocaine epinephrine

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

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No