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Axillary Nerve BlockPhase 3NCT02385097

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

A Phase 3 study testing Chloroprocaine HCl 2% and Ropivacaine 0.75% in people with Axillary Nerve Block, run by Sintetica SA at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axillary Nerve Block
What is being tested?
Chloroprocaine HCl 2% and Ropivacaine 0.75%
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
1 siteSwitzerland
Study dates
Apr 2015to May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Informed consent: signed written informed consent before inclusion in the study
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Claudio Camponovo

    Gravesano, Lugano, CH-6929

Other trials in Switzerland

About this study

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

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.

Read the detailed description

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

Being tested
Chloroprocaine HCl 2%, Ropivacaine 0.75%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chloroprocaine HCl 2%Drug

    Also called Ampres

    Single Administration (20mL) by Axillary Nerve Route

  • Ropivacaine 0.75%Drug

    Also called Naropin

    Single Administration (20mL) by Axillary Nerve Route

Study groups in NCT02385097
Study groupRoleWhat they receive
Chloroprocaine HCl 2% (20 mg/mL)ExperimentalChloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Receives: Drug: Chloroprocaine HCl 2%
Ropivacaine 0.75% (7.5 mg/mL)Active comparatorRopivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Receives: Drug: Ropivacaine 0.75%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 45 min from the time of readiness of surgery

Secondary outcomes (13)

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

    Time period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories

    Measured: Up to 1 h after last perineural injection

  2. Time to Onset of Motor Block

    Time period from completion of the final perineural injection (time 0 h) to achievement of motor block

    Measured: Up to 1 h after last perineural injection

  3. Time to Regression of Sensory Block

    Will be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory

    Measured: Up to 12 hrs after surgery

  4. Time to Regression of Motor Block

    Will be deemed to have occurred when motor score is ≥ 3 (Modified Bromage scale) in any nerve territory (Modified Bromage scale: 0-No movement in relevant muscle group,1-Flicker of movement in relevant muscle group,2-Ability to move relevant muscle group against gravity but inability to move against resistance,3-Reduced power but ability to move muscle group against resistance,4-Full power in relevant muscle group)

    Measured: Up to 12 hrs after surgery

  5. Partecipants Received Rescue Anaesthesia or Rescue Analgesia

    partecipants received rescue anaesthesia or rescue analgesia from completion of the final perineural injection (time 0 hour) to administration of first rescue anaesthesia or analgesia (supplementation)

    Measured: 45 min from the time of readiness of surgery

  6. Number of Subjects Who Received Post-operative Analgesia

    Number of subjects who received the first post-operative analgesia

    Measured: From surgery day to 24 hrs post surgery

  7. Time to Eligibility for Home Discharge

    Time from completion of the final perineural injection (time 0 h) to the time when the criteria for discharge are met, even if, according to the hospital procedures, the patient is discharged from the hospital at a later time

    Measured: from surgery day to 24h post surgery

  8. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Number of Participants with Treatment-emergent Adverse Events (TEAEs) occurring or worsening after the first dose of IMP

    Measured: from surgery day to day 6 +/- 1 after surgery

  9. Neurological Symptoms

    Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site)

    Measured: from surgery day to day 6 +/- 1 after surgery

  10. Heart Rate

    The following normal ranges Heart Rate parameters will be used:

    50-90 beats/min

    Measured: from surgery day to 24 hrs post surgery

  11. Blood Pressure

    The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used:

    Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg

    Measured: from surgery day to 24 hrs post surgery

  12. SpO2

    The following normal ranges SpO2 parameters will be used:

    Peripheral Oxygen Saturation: ≥ 95%

    Measured: from surgery day to 24 hrs post surgery

  13. Number of Participants With Normal Electrocardiogram (ECG) Parameters

    Number of Participants with Normal Electrocardiogram (ECG) Parameters. The following normal ranges ECG parameters will be used:

    Heart Rate: 50-90 beats/min PR Interval: 100-220 msec QRS Duration: ≤ 120 msec QT Interval: ≤ 500 msec

    Measured: from surgery day to 24 hrs post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385097
Sponsor's protocol ID
CHL.2/01-2014/M
Status last verified
Jun 2021
First submitted
20 Feb 2015
Last updated
15 Jul 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33976374

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chloroprocaine HCl 2% and Ropivacaine 0.75% in people with Axillary Nerve Block, run by Sintetica SA at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Successful Block for Distal Upper Limb Surgeries (time frame: 45 min from the time of readiness of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.

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