Clinical Trial Results:
Randomised comparative trial of Bupivacaine and 2-Chloroprocaine by caesarean section.
Summary
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EudraCT number |
2013-002815-88 |
Trial protocol |
BE |
Global end of trial date |
26 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Sep 2020
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First version publication date |
30 Sep 2020
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Other versions |
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Summary report(s) |
Article |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BUPCHLOR1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UZ Brussel
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Sponsor organisation address |
Laarbeeklaan 101, Jette, Belgium, 1090
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Public contact |
Department of Anesthesiology, UZ Brussel, 24763618 24763618, luc.puis@uzbrussel.be
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Scientific contact |
Department of Anesthesiology, UZ Brussel, 24763618 24763618, luc.puis@uzbrussel.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Mar 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Mar 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The goal of this trial is to investigate the efficacy of the IMP during c-section with and without the use of Sufenta: As well as start of action, duration of action, the degree of motor and sensory block as well as the hight of the block itselfs will be investigated.
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Protection of trial subjects |
If patients of a certain group was in distress there was a rescue dose available.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jul 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
60
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
Inclusion: in-term (≥ 37 weeks),ASA I,II, planned CS,uncomplicated, singleton pregnancy, age 18-40 years. Exclusion: ASA III,IV, urgent/emergent CS, twin/multiple pregnancy, gestational age<37 weeks, BMI > 35, maternal height < 150 cm, foetus with known or suggested congenital malformations, known allergy for anaesthetics and (pre)eclampsia. | ||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||
Roles blinded |
Subject | ||||||||||||
Blinding implementation details |
Anesthesiologist receives an envelop to know which group the patient will be in. Patient is not informed of which medication they will receive.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group C | ||||||||||||
Arm description |
Patients received 2-chloroprocaine. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Chloroprocaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
40 mg 2-chloroprocaine spinal-epidural
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Arm title
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Group C+S | ||||||||||||
Arm description |
Patients receive 2-chloroprocaine and sufentanil | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Chloroprocaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
40 mg 2-chloroprocaine spinal-epidural
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Investigational medicinal product name |
Sufentanil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
1 mcg sufentanil spinal-epidural
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Arm title
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Group B+S | ||||||||||||
Arm description |
Hyperbaric bupivacaine (9 mg) with sufentanil (1 mcg) | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Sufentanil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
1 mcg sufentanil spinal-epidural
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Investigational medicinal product name |
Bupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
Hyperbaric bupivacaine 9 mg and 1 mcg of sufentanil were spinal-epidural given to patients.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group C
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Reporting group description |
Patients received 2-chloroprocaine. | ||
Reporting group title |
Group C+S
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Reporting group description |
Patients receive 2-chloroprocaine and sufentanil | ||
Reporting group title |
Group B+S
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Reporting group description |
Hyperbaric bupivacaine (9 mg) with sufentanil (1 mcg) |
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End point title |
Time to motor block | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time in minutes starting from IMP injection to motor block.
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Statistical analysis title |
Mann-Whitney U test | ||||||||||||||||
Comparison groups |
Group C v Group C+S v Group B+S
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
t-test | ||||||||||||||||
Comparison groups |
Group C v Group C+S v Group B+S
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
t-test, 1-sided | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Fischer | ||||||||||||||||
Comparison groups |
Group C v Group C+S v Group B+S
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Fisher exact | ||||||||||||||||
Confidence interval |
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End point title |
Time to motor block resolution | ||||||||||||||||
End point description |
How long does it take for the patients to have full motor recovery after the caesarean.
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End point type |
Secondary
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End point timeframe |
Time after surgery in minutes.
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Statistical analysis title |
Mann-Whitney U test | ||||||||||||||||
Comparison groups |
Group C v Group C+S v Group B+S
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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Notes [1] - randomly selected values X and Y from two populations, the probability that X is greater than Y is equal to the probability that Y is greater than X. |
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Statistical analysis title |
T-test between groups | ||||||||||||||||
Comparison groups |
Group C v Group C+S v Group B+S
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
t-test, 1-sided | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Fisher | ||||||||||||||||
Comparison groups |
Group C v Group C+S v Group B+S
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Fisher exact | ||||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the caesarean and 1 day postop.
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Adverse event reporting additional description |
There were no Adverse Events reported.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4.0
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no Adverse Events reported. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |