Trial Outcomes & Findings for Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block (NCT NCT02385097)
NCT ID: NCT02385097
Last Updated: 2021-07-15
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
45 min from the time of readiness of surgery
Results posted on
2021-07-15
Participant Flow
From April 2015 to May 2017 in Medical clinic and Hospital
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
105
|
|
Overall Study
COMPLETED
|
106
|
105
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block
Baseline characteristics by cohort
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=106 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=105 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 18.7 • n=7 Participants
|
54 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Body Mass Index
|
25.58 kg/m^2
STANDARD_DEVIATION 3.83 • n=5 Participants
|
25.61 kg/m^2
STANDARD_DEVIATION 3.55 • n=7 Participants
|
25.60 kg/m^2
STANDARD_DEVIATION 3.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: 45 min from the time of readiness of surgeryPopulation: 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.
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).
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
|
96 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Up to 1 h after last perineural injectionTime period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
|
10 minutes
Interval 10.0 to 15.0
|
15 minutes
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to 1 h after last perineural injectionTime period from completion of the final perineural injection (time 0 h) to achievement of motor block
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Time to Onset of Motor Block
|
10 minutes
Interval 5.0 to 10.0
|
10 minutes
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 12 hrs after surgeryWill be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Time to Regression of Sensory Block
|
68 minutes
Interval 64.0 to 75.0
|
451 minutes
Interval 413.0 to 480.0
|
SECONDARY outcome
Timeframe: Up to 12 hrs after surgeryWill 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)
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Time to Regression of Motor Block
|
65 minutes
Interval 60.0 to 69.0
|
415 minutes
Interval 388.0 to 460.0
|
SECONDARY outcome
Timeframe: 45 min from the time of readiness of surgerypartecipants 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)
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Partecipants Received Rescue Anaesthesia or Rescue Analgesia
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From surgery day to 24 hrs post surgeryNumber of subjects who received the first post-operative analgesia
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Number of Subjects Who Received Post-operative Analgesia
|
49 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: from surgery day to 24h post surgeryTime 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
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Time to Eligibility for Home Discharge
|
161 minutes
Interval 155.0 to 170.0
|
355.5 minutes
Interval 260.0 to 450.0
|
SECONDARY outcome
Timeframe: from surgery day to day 6 +/- 1 after surgeryNumber of Participants with Treatment-emergent Adverse Events (TEAEs) occurring or worsening after the first dose of IMP
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
58 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: from surgery day to day 6 +/- 1 after surgeryNumber of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site)
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Neurological Symptoms
hypoesthesia : discharge
|
5 Participants
|
14 Participants
|
|
Neurological Symptoms
burning : discharge
|
8 Participants
|
1 Participants
|
|
Neurological Symptoms
burning : day 7
|
6 Participants
|
4 Participants
|
|
Neurological Symptoms
tingling : discharge
|
8 Participants
|
25 Participants
|
|
Neurological Symptoms
tingling : day 7
|
5 Participants
|
6 Participants
|
|
Neurological Symptoms
Pins and needles sensation : discharge
|
1 Participants
|
5 Participants
|
|
Neurological Symptoms
Pins and needles sensation : day 7
|
2 Participants
|
0 Participants
|
|
Neurological Symptoms
Pricking : discharge
|
8 Participants
|
5 Participants
|
|
Neurological Symptoms
Pricking : day 7
|
0 Participants
|
0 Participants
|
|
Neurological Symptoms
aching : discharge
|
10 Participants
|
6 Participants
|
|
Neurological Symptoms
aching : day 7
|
4 Participants
|
3 Participants
|
|
Neurological Symptoms
numbness : discharge
|
2 Participants
|
27 Participants
|
|
Neurological Symptoms
numbness : day 7
|
2 Participants
|
3 Participants
|
|
Neurological Symptoms
hypoesthesia : day 7
|
5 Participants
|
5 Participants
|
|
Neurological Symptoms
Pain surgery site : discharge
|
0 Participants
|
1 Participants
|
|
Neurological Symptoms
Pain surgery site : day 7
|
0 Participants
|
0 Participants
|
|
Neurological Symptoms
diffuse hair loss : discharge
|
0 Participants
|
0 Participants
|
|
Neurological Symptoms
diffuse hair loss : day 7
|
0 Participants
|
1 Participants
|
|
Neurological Symptoms
headache : discharge
|
0 Participants
|
0 Participants
|
|
Neurological Symptoms
headache : day 7
|
2 Participants
|
0 Participants
|
|
Neurological Symptoms
itching : discharge
|
0 Participants
|
0 Participants
|
|
Neurological Symptoms
itching : day 7
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from surgery day to 24 hrs post surgeryThe following normal ranges Heart Rate parameters will be used: 50-90 beats/min
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Heart Rate
screening
|
73 beats/minutes
Standard Deviation 12
|
73.6 beats/minutes
Standard Deviation 12.3
|
|
Heart Rate
baseline
|
72.5 beats/minutes
Standard Deviation 10.8
|
71.6 beats/minutes
Standard Deviation 12.5
|
|
Heart Rate
discharge
|
71.5 beats/minutes
Standard Deviation 11.5
|
73 beats/minutes
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: from surgery day to 24 hrs post surgeryThe following normal ranges Systolic and Diastolic Blood Pressure parameters will be used: Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Blood Pressure
Systolic Blood Pressure at baseline
|
136.6 mmHg
Standard Deviation 18.9
|
138 mmHg
Standard Deviation 19.1
|
|
Blood Pressure
Systolic Blood Pressure at screening
|
137 mmHg
Standard Deviation 20.5
|
136.2 mmHg
Standard Deviation 18.2
|
|
Blood Pressure
Systolic Blood Pressure at discharge
|
130.5 mmHg
Standard Deviation 17.8
|
130.1 mmHg
Standard Deviation 17.3
|
|
Blood Pressure
Diastolic Blood Pressure at screening
|
80.8 mmHg
Standard Deviation 11.4
|
80.5 mmHg
Standard Deviation 9.8
|
|
Blood Pressure
Diastolic Blood Pressure at baseline
|
78.2 mmHg
Standard Deviation 10.7
|
80.1 mmHg
Standard Deviation 10.4
|
|
Blood Pressure
Diastolic Blood Pressure at discharge
|
74.4 mmHg
Standard Deviation 11.1
|
75.4 mmHg
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: from surgery day to 24 hrs post surgeryThe following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
SpO2
baseline
|
97.05 percentage of SpO2
Standard Deviation 1.51
|
97.36 percentage of SpO2
Standard Deviation 1.69
|
|
SpO2
discharge
|
97.47 percentage of SpO2
Standard Deviation 1.52
|
97.61 percentage of SpO2
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: from surgery day to 24 hrs post surgeryNumber 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
Outcome measures
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=105 Participants
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=104 Participants
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Number of Participants With Normal Electrocardiogram (ECG) Parameters
|
105 Participants
|
104 Participants
|
Adverse Events
Chloroprocaine HCl 2% (20 mg/mL)
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Ropivacaine 0.75% (7.5 mg/mL)
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chloroprocaine HCl 2% (20 mg/mL)
n=106 participants at risk
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route
|
Ropivacaine 0.75% (7.5 mg/mL)
n=105 participants at risk
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
45.3%
48/106 • Number of events 50 • 7 days
|
39.0%
41/105 • Number of events 43 • 7 days
|
|
Nervous system disorders
Hypoaestesia
|
8.5%
9/106 • Number of events 10 • 7 days
|
36.2%
38/105 • Number of events 44 • 7 days
|
|
Nervous system disorders
Paraestesia
|
16.0%
17/106 • Number of events 22 • 7 days
|
26.7%
28/105 • Number of events 40 • 7 days
|
|
Nervous system disorders
burning sensation
|
10.4%
11/106 • Number of events 11 • 7 days
|
4.8%
5/105 • Number of events 5 • 7 days
|
|
Nervous system disorders
headache
|
2.8%
3/106 • Number of events 3 • 7 days
|
0.95%
1/105 • Number of events 1 • 7 days
|
|
Nervous system disorders
sensorimotor disorder
|
0.00%
0/106 • 7 days
|
0.95%
1/105 • Number of events 1 • 7 days
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
10.4%
11/106 • Number of events 12 • 7 days
|
4.8%
5/105 • Number of events 5 • 7 days
|
|
General disorders
injection site pain
|
5.7%
6/106 • Number of events 6 • 7 days
|
4.8%
5/105 • Number of events 5 • 7 days
|
|
Gastrointestinal disorders
nausea
|
0.94%
1/106 • Number of events 1 • 7 days
|
3.8%
4/105 • Number of events 4 • 7 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/106 • 7 days
|
0.95%
1/105 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/106 • 7 days
|
0.95%
1/105 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/106 • 7 days
|
0.95%
1/105 • Number of events 1 • 7 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/106 • 7 days
|
0.95%
1/105 • Number of events 1 • 7 days
|
Additional Information
Dr.Elisabetta Donati, Corporate Director Scientific Affairs
Sintetica SA
Phone: +41.91.640.42.50
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place