Clinical Trial Results:
Programmed Intermittent Epidural Bolus versus Continuous Epidural Infusion for third trimester voluntary termination of pregnancy analgesia : a randomized study.
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Summary
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EudraCT number |
2015-001738-33 |
Trial protocol |
FR |
Global end of trial date |
11 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jun 2021
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First version publication date |
05 Jun 2021
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Other versions |
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Summary report(s) |
RRF PCEA IMG statistical report |
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 |
I14032
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02744482 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CHU de LIMOGES
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Sponsor organisation address |
2 Avenue Martin Luther King -, Limoges, France, 87042
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Public contact |
Director Recherche and Innovation, CHU de LIMOGES, +33 555056349, drc@chu-limoges.fr
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Scientific contact |
Principal investigator, CHU de LIMOGES, +33 555052103, patrick.senges@chu-limoges.fr
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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 |
21 Nov 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Dec 2018
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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 |
Demonstrate the benefit PIEB mode compared with the standard mode CEI in the Voluntary termination of pregancy after 22 weeks in terms of satisfaction with analgesia.
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Protection of trial subjects |
no particular protection
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2015
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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 |
France: 37
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Worldwide total number of subjects |
37
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EEA total number of subjects |
37
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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) |
37
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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 |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
no pre-assignment period | ||||||||||||||||||
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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 |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PCEA-BIP | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
levobupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
Maximum of 342,92 mg per day in mix with Sufentanil citrate and clonidine for epidural use
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Investigational medicinal product name |
Sufentanil citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
Maximum of 189,45 µg per day in mix with levobupivacaine and clonidine for epidural use
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Investigational medicinal product name |
Clonidine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
Maximum of 669,3 µg per day in mix with levobupivacaine and sufentanil citrate for epidural use
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Arm title
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PCEA-DC | ||||||||||||||||||
Arm description |
-Injection of a 2 mL initial epidural loading dose consisting of a blend of 8 mL of levobupivacaine 2,5mg/mL plus 2 mL of sufentanil 5 µg/mL to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. -Injection of the rest of the loading dose (8mL). -In this group the pump is programmed to deliver a continuous infusion at 10 mL /h consisting of levobupivacaine 0,573 mg/mL plus sufentanil 0,37 µg/mL plus clonidine 1,38 µg/mL. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. -If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 30/100 with a limit of 3 injections by hour before that the anesthetist to be called. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
levobupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
Maximum of 350,09 mg per day in mix with Sufentanil citrate and clonidine for epidural use
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Investigational medicinal product name |
Sufentanil citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
Maximum of 192,23 µg per day in mix with levobupivacaine and clonidine for epidural use
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Investigational medicinal product name |
Clonidine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
Maximum of 685,08 µg per day in mix with levobupivacaine and sufentanil citrate for epidural use
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Baseline characteristics reporting groups
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Reporting group title |
PCEA-BIP
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PCEA-DC
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Reporting group description |
-Injection of a 2 mL initial epidural loading dose consisting of a blend of 8 mL of levobupivacaine 2,5mg/mL plus 2 mL of sufentanil 5 µg/mL to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. -Injection of the rest of the loading dose (8mL). -In this group the pump is programmed to deliver a continuous infusion at 10 mL /h consisting of levobupivacaine 0,573 mg/mL plus sufentanil 0,37 µg/mL plus clonidine 1,38 µg/mL. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. -If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 30/100 with a limit of 3 injections by hour before that the anesthetist to be called. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PCEA-BIP
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Reporting group description |
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Reporting group title |
PCEA-DC
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Reporting group description |
-Injection of a 2 mL initial epidural loading dose consisting of a blend of 8 mL of levobupivacaine 2,5mg/mL plus 2 mL of sufentanil 5 µg/mL to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. -Injection of the rest of the loading dose (8mL). -In this group the pump is programmed to deliver a continuous infusion at 10 mL /h consisting of levobupivacaine 0,573 mg/mL plus sufentanil 0,37 µg/mL plus clonidine 1,38 µg/mL. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. -If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 30/100 with a limit of 3 injections by hour before that the anesthetist to be called. | ||
Subject analysis set title |
PCEA-BIP
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Patients included in PCEA-BIP arm and received procedure
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Subject analysis set title |
PCEA-DC
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Patients included in PCEA-DC arm and receivded procedure
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End point title |
Satisfaction visual analog scale (SVAS) measurment [1] | ||||||||||||
End point description |
The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to " completely unsatisfied " and 100 to " completely satisfied ".
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End point type |
Primary
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End point timeframe |
end of participation
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: see statistical report joined |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
overall trial
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22
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Reporting groups
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Reporting group title |
all patients
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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20 Nov 2015 |
- Modification of service practices
- Modification of the type of scale taken into account when calculating the number of subjects required
- Modification of the nature of the randomization, the nature of the CRF and the correction of the maximum dose per 14h received by the patients depending on the arm |
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26 Dec 2017 |
- Modification RCP catapressan and sufenta
- Deletion of the non-inclusion criteria for patients treated with sultopride
- Modification of a CNI to add the taking of agniste to the nalmefene |
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22 Mar 2018 |
Prolongation of inclusion period |
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19 Oct 2018 |
prolongation of inclusion period |
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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 | |||
