Clinical trial

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

Name

CTA no: 2023-510028-63-00

Description

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.

Trial arms

Trial start

2024-04-18

Estimated PCD

2024-08-03

Trial end

2024-09-03

Status

Recruiting

Phase

Early phase I

Treatment

Ropivacaine 0.5% Injectable Solution

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

Arms:

Control group: Ropi-5, 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)

Arms:

Intervention group 1: Ropi-5+Lido-20, 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)

Arms:

Intervention group 2: Ropi-7.5+Lido-20

Size

Primary endpoint

Total time to breakthrough pain

24 hours

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}

Updated at

2024-04-24

1 organization

2 products

6 indications

Organization

Nordsjaellands Hospital

Product

Ropivacaine

Indication

Nerve Block

Indication