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| Name | Class |
|---|---|
| Cross S.A. | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Experimental | Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL |
|
| Ropivacaine 0.75% (7.5 mg/mL) | Active Comparator | Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine HCl 2% | Drug | Single Administration (20mL) by Axillary Nerve Route |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 1 h after last perineural injection |
| Time to Onset of Motor Block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Claudio Camponovo | Gravesano | Lugano | CH-6929 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33976374 | Derived | 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. |
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From April 2015 to May 2017 in Medical clinic and Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Chloroprocaine HCl 2% (20 mg/mL) | Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route |
| FG001 | Ropivacaine 0.75% (7.5 mg/mL) | Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
211 patients were enrolled in the study. 106 of the enrolled patients were randomised to the Test treatment group and 105 patients to the Reference treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chloroprocaine HCl 2% (20 mg/mL) | Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route |
| BG001 | Ropivacaine 0.75% (7.5 mg/mL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 211 patients were enrolled in the study. 106 of the enrolled patients were randomised to the Test treatment group and 105 patients to the Reference treatment group. Two subjects, one in the Test and one in the Reference treatment group discontinued the study before treatment (withdrawal by subject). In the Test treatment group, 105 patients were treated and completed the study. In the Reference treatment group, 104 patients were treated, 103 of them completed the study. | Posted | Count of Participants | Participants | 45 min from the time of readiness of surgery |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chloroprocaine HCl 2% (20 mg/mL) | Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Elisabetta Donati, Corporate Director Scientific Affairs | Sintetica SA | +41.91.640.42.50 | edonati@sintetica.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2014 | Apr 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine 0.75% | Drug | Single Administration (20mL) by Axillary Nerve Route |
|
|
Time period from completion of the final perineural injection (time 0 h) to achievement of motor block |
| Up to 1 h after last perineural injection |
| 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 | Up to 12 hrs after surgery |
| 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) | Up to 12 hrs after surgery |
| 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) | 45 min from the time of readiness of surgery |
| Number of Subjects Who Received Post-operative Analgesia | Number of subjects who received the first post-operative analgesia | From surgery day to 24 hrs post surgery |
| 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 | from surgery day to 24h post surgery |
| 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 | from surgery day to day 6 +/- 1 after surgery |
| Neurological Symptoms | Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site) | from surgery day to day 6 +/- 1 after surgery |
| Heart Rate | The following normal ranges Heart Rate parameters will be used: 50-90 beats/min | from surgery day to 24 hrs post surgery |
| 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 | from surgery day to 24 hrs post surgery |
| SpO2 | The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% | from surgery day to 24 hrs post surgery |
| 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 | from surgery day to 24 hrs post surgery |
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
| OG001 | Ropivacaine 0.75% (7.5 mg/mL) | Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route |
|
|
| Secondary | 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 | Posted | Median | 95% Confidence Interval | minutes | Up to 1 h after last perineural injection |
|
|
|
| Secondary | Time to Onset of Motor Block | Time period from completion of the final perineural injection (time 0 h) to achievement of motor block | Posted | Median | 95% Confidence Interval | minutes | Up to 1 h after last perineural injection |
|
|
|
| Secondary | 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 | Posted | Median | 95% Confidence Interval | minutes | Up to 12 hrs after surgery |
|
|
|
| Secondary | 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) | Posted | Median | 95% Confidence Interval | minutes | Up to 12 hrs after surgery |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 45 min from the time of readiness of surgery |
|
|
|
| Secondary | Number of Subjects Who Received Post-operative Analgesia | Number of subjects who received the first post-operative analgesia | Posted | Count of Participants | Participants | From surgery day to 24 hrs post surgery |
|
|
|
| Secondary | 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 | Posted | Median | 95% Confidence Interval | minutes | from surgery day to 24h post surgery |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | from surgery day to day 6 +/- 1 after surgery |
|
|
|
| Secondary | Neurological Symptoms | Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site) | Posted | Count of Participants | Participants | from surgery day to day 6 +/- 1 after surgery |
|
|
|
| Secondary | Heart Rate | The following normal ranges Heart Rate parameters will be used: 50-90 beats/min | Posted | Mean | Standard Deviation | beats/minutes | from surgery day to 24 hrs post surgery |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mmHg | from surgery day to 24 hrs post surgery |
|
|
|
| Secondary | SpO2 | The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% | Posted | Mean | Standard Deviation | percentage of SpO2 | from surgery day to 24 hrs post surgery |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | from surgery day to 24 hrs post surgery |
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| 58 |
| 106 |
| EG001 | Ropivacaine 0.75% (7.5 mg/mL) | Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route | 0 | 105 | 0 | 105 | 76 | 105 |
| Hypoaestesia | Nervous system disorders | Systematic Assessment |
|
| Paraestesia | Nervous system disorders | Systematic Assessment |
|
| burning sensation | Nervous system disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| sensorimotor disorder | Nervous system disorders | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| injection site pain | General disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| tingling : discharge |
|
| tingling : day 7 |
|
| Pins and needles sensation : discharge |
|
| Pins and needles sensation : day 7 |
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| Pricking : discharge |
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| Pricking : day 7 |
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| aching : discharge |
|
| aching : day 7 |
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| numbness : discharge |
|
| numbness : day 7 |
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| hypoesthesia : discharge |
|
| hypoesthesia : day 7 |
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| Pain surgery site : discharge |
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| Pain surgery site : day 7 |
|
| diffuse hair loss : discharge |
|
| diffuse hair loss : day 7 |
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| headache : discharge |
|
| headache : day 7 |
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| itching : discharge |
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| itching : day 7 |
|
| discharge |
|
| Systolic Blood Pressure at discharge |
|
| Diastolic Blood Pressure at screening |
|
| Diastolic Blood Pressure at baseline |
|
| Diastolic Blood Pressure at discharge |
|