Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

Nordsjaellands Hospital

Status and phase: Completed; Phase 3

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

Treatments: Drug: Lidocaine epinephrine; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.75% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06381622

CTA no: 2023-510028-63-00

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups

Control group: Ropi-5

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine 0.5% Injectable Solution

Intervention group 1: Ropi-5+Lido-20

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine 0.5% Injectable Solution

Drug: Lidocaine epinephrine

Intervention group 2: Ropi-7.5+Lido-20

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine 0.75% Injectable Solution

Drug: Lidocaine epinephrine