Clinical Trial Results:
Conventional patient controlled epidural analgesia (PCEA) versus programmed intermittent epidural boluses (PIEB) for labor analgesia: a randomized, double blind study in nulliparous women
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Summary
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EudraCT number |
2015-004600-30 |
Trial protocol |
BE |
Global end of trial date |
27 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Dec 2020
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First version publication date |
13 Dec 2020
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Other versions |
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Summary report(s) |
PIEB for labour analgesia |
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 |
mvdv/er102015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University Hospital Leuven
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Sponsor organisation address |
Herestaat 29, Leuven, Belgium,
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Public contact |
research anesthesiology, University Hospitals leuven, +32 16344270, marc.vandevelde@uzleuven.be
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Scientific contact |
research anesthesiology, University Hospitals leuven, +32 16344270, marc.vandevelde@uzleuven.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 |
25 Nov 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Feb 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Feb 2017
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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 |
Comparison of two techniques to maintain labor analgesia: Programmed intermittent epidural boluses (PIEB) with patient controlled epidural analgesia (PCEA) and the conventional technique, PCEA
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Protection of trial subjects |
Before initiation of labor analgesia, an IV infusion of 500 mL Ringer’s lactate is started and baseline maternal heart rate, noninvasive arterial blood pressure and fetal heart rate are recorded.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2016
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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: 125
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Worldwide total number of subjects |
125
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EEA total number of subjects |
125
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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) |
125
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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 |
149 patients were assessed for eligibility; 130 patients were enrolled and randomized between January 2016 and February 2017 | |||||||||
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Pre-assignment
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Screening details |
130 patients were enrolled The included patients were randomized to two groups with 65 patients in each group. In the PCEA group 4 patients were excluded because of epidural catheter failure or protocol violation. In the PIEB group, 1 patient was excluded due to a failed epidural catheter. | |||||||||
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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-group | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Naropin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Epidural use
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Dosage and administration details |
In all parturients, labor analgesia is induced using a CSE technique in the sitting position at the level of L3-L4 or L4-L5 lumbar interspace using the LOR to saline technique with a 16-gauge Tuohy epidural needle and a needle through needle technique with a 27-gauge spinal Whitacre needle. All patients receive an initial intrathecal loading dose of 4.2 mg of ropivacaine and 2.5 mcg sufentanil (>ED95) 15 in a volume of 3.5mL: ropivacaïne 0.120% + sufentanil 0.75 microgram/mL. A multiorifice epidural catheter is inserted 4-5 cm into the epidural space and secured. The same ropivacaine-sufentanil solution is used for epidural infusion and intermittent boluses during maintenance. In the conventional PCEA group, a PCEA is initiated 5 minutes after the spinal injection. The bolus is set at 5 mL with a lock-out of 12 minutes.
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Arm title
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PIEB-PCEA group | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Naropin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Epidural use
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Dosage and administration details |
All parturients received intrathecally 4mL of ropivacaine 0.120% and sufentanil 0.75 mcg/mL. The spinal needle was removed and a multi-orifice epidural catheter was inserted 4 cm into the epidural space. Analgesia was maintained using an hourly programmed bolus of 10 mL supplemented by PCEA boluses of 5 mL with a lock-out of 20’. The hourly bolus was administered for the first time 30’ after initiation of the PIEB pump. In both groups, the pump was initiated 15’ after the intrathecal injection was completed and if VAS scores were <20 mm. If VAS scores were >20 mm patients were excluded from the study.
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Baseline characteristics reporting groups
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Reporting group title |
PCEA-group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PIEB-PCEA group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PCEA-group
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Reporting group description |
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Reporting group title |
PIEB-PCEA group
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Reporting group description |
- | ||
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End point title |
breakthrough pain | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary outcome parameter was the occurrence of breakthrough pain. Breakthrough pain was defined as a VAS score >30 mm for which the parturient requested additional analgesia after at least 1 PCEA bolus was administered. If breakthrough pain occurred
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Statistical analysis title |
breakthrough pain | |||||||||
Statistical analysis description |
A binary logistic regression with a logit link function was used for the analysis of the primary outcome. In a univariable logistic regression, the indicator variable for breakthrough pain is regressed on the treatment conditions.
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Comparison groups |
PCEA-group v PIEB-PCEA group
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
until 24 hours after delivery.
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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 |
21.1
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| Frequency threshold for reporting non-serious adverse events: 0.5% | |||
| 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: NO AE 's 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 | |||
