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

NCT02385097 | Completed Phase 3 Results DMC

• 1 other identifier: CHL.2/01-2014/M
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Block for Distal Upper Limb Surgeries

  Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).

  45 min from the time of readiness of surgery

Secondary Outcomes (13)

• Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)

  Up to 1 h after last perineural injection

• Time to Onset of Motor Block

  Up to 1 h after last perineural injection

• Time to Regression of Sensory Block

  Up to 12 hrs after surgery

• Time to Regression of Motor Block

  Up to 12 hrs after surgery

• Partecipants Received Rescue Anaesthesia or Rescue Analgesia

  45 min from the time of readiness of surgery

Study Arms (2)

Chloroprocaine HCl 2% (20 mg/mL)

EXPERIMENTAL

Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL

Drug: Chloroprocaine HCl 2%

Ropivacaine 0.75% (7.5 mg/mL)

ACTIVE COMPARATOR

Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL

Drug: Ropivacaine 0.75%

Interventions

Chloroprocaine HCl 2% DRUG

Single Administration (20mL) by Axillary Nerve Route

Also known as: Ampres

Chloroprocaine HCl 2% (20 mg/mL)

Ropivacaine 0.75% DRUG

Single Administration (20mL) by Axillary Nerve Route

Also known as: Naropin

Ropivacaine 0.75% (7.5 mg/mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex and surgery: male and female patients scheduled for short duration (\< 60 min) distal upper limb surgery under axillary nerve block anaesthesia
• Age: ≥ 18 years old
• Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
• ASA physical status: I-III
• 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

You may not qualify if:

• 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
• Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement
• ASA physical status: IV-V
• Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia)
• Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents)
• Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
• 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
• 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
• 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
• Drug, alcohol: history of drug or alcohol abuse
• Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women

Sponsors & Collaborators

• Sintetica SA: lead
• Cross S.A.: collaborator

Study Sites (1)

Claudio Camponovo

Gravesano, Lugano, CH-6929, Switzerland

Location

Related Publications (1)

• Sulyok I, Camponovo C, Zotti O, Haslik W, Kostenberger M, Likar R, Leuratti C, Donati E, Kimberger O. A randomised, non-inferiority study of chloroprocaine 2% and ropivacaine 0.75% in ultrasound-guided axillary block. Sci Rep. 2021 May 11;11(1):10035. doi: 10.1038/s41598-021-89483-y.

  PMID: 33976374 DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr.Elisabetta Donati, Corporate Director Scientific Affairs
• Organization: Sintetica SA

edonati@sintetica.com

+41.91.640.42.50

Study Officials

• Oliver Kimberger, Prof

  Department of General Anesthesia and Intensive Care Medicine, Spitalgasse 23, 1090 Vienna, Austria

  PRINCIPAL INVESTIGATOR

• Claudio Camponovo, MD

  Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland

  PRINCIPAL INVESTIGATOR

• Andrea Saporito, MD

  Department of Anaesthesiology, Ospedale Regionale di Bellinzona, CH-6500 Bellinzona, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 11, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Locations

CH (1)