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Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block

NCT02385097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2021-07-15

Study results available
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Summary

The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.

Conditions

  • Axillary Nerve Block

Interventions

DRUG

Chloroprocaine HCl 2%

Single Administration (20mL) by Axillary Nerve Route

DRUG

Ropivacaine 0.75%

Single Administration (20mL) by Axillary Nerve Route

Sponsors & Collaborators

  • Cross S.A.

    collaborator INDUSTRY

  • Sintetica SA

    lead INDUSTRY

Principal Investigators

  • Oliver Kimberger, Prof · Department of General Anesthesia and Intensive Care Medicine, Spitalgasse 23, 1090 Vienna, Austria

  • Claudio Camponovo, MD · Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland

  • Andrea Saporito, MD · Department of Anaesthesiology, Ospedale Regionale di Bellinzona, CH-6500 Bellinzona, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385097 on ClinicalTrials.gov