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Chloroprocaine 2% - Axillary Block

Information source: Sintetica SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Axillary Nerve Block

Intervention: Chloroprocaine HCl 2% (Drug); Ropivacaine 0.75% (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sintetica SA

Official(s) and/or principal investigator(s):
Hinnerk Wulf, MD, Principal Investigator, Affiliation: Department of Anesthesiology and Intensive Care Medicine, University Hospital, D-35033 Marburg, Germany
Claudio Camponovo, MD, Principal Investigator, Affiliation: Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland
Andrea Saporito, MD, Principal Investigator, Affiliation: Department of Anaesthesiology, Ospedale Regionale di Bellinzona e Valli-Bellinzona, CH-6500 Bellinzona, Switzerland

Overall contact:
Elisabetta Donati, MD, Phone: +41(0)91 640 42 5, Ext: 0041, Email: CHL.2_01_2014_M@sintetica.com

Summary

This 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, without any supplementation in the first 45 min (see definitions below), calculated from the time of readiness for surgery (complete sensory block). Successful block: anaesthesia adequate for the surgery (complete sensory block), without any supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the time of readiness for surgery (complete sensory block). Supplementation: i. v. premedication or general anaesthesia or pre- or intra-operative systemic analgesia or additional local anaesthetic infiltration

Clinical Details

Official title: A Prospective, Randomised, Non-inferiority Study of Chloroprocaine 2% and the Active Control Ropivacaine 0.75% (AstraZeneca) in Ultrasound-guided Axillary Nerve Block for Short-duration Distal Upper Limb Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Successful block

Secondary outcome:

Time to onset of sensory block (corresponding to readiness for surgery)

Time to onset of motor block

Time to regression of sensory block

Time to regression of motor block

Time to administration of rescue anaesthesia or rescue analgesia

Time to first post-operative analgesia

Time to eligibility for home discharge

Treatment-emergent adverse events (TEAEs)

Neurological symptoms (e.g. paraesthesia, motor function problems and pain at the injection site),

Heart rate

Blood pressure

SpO2

ECG

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia 2. Age: ≥ 18 years old

3. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive

4. ASA physical status: I-III 5. Informed consent: signed written informed consent before inclusion in the study 6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study Exclusion Criteria: 1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities 2. Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement 3. ASA physical status: IV-V 4. Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia) 5. Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents) 6. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics 7. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure 8. Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed 9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study 10. Drug, alcohol: history of drug or alcohol abuse 11. Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women

Locations and Contacts

Elisabetta Donati, MD, Phone: +41(0)91 640 42 5, Ext: 0041, Email: CHL.2_01_2014_M@sintetica.com

Claudio Camponovo, Gravesano, Lugano CH-6929, Switzerland; Recruiting
Additional Information

Starting date: March 2015
Last updated: July 22, 2015

Page last updated: August 23, 2015

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