Clinical Trial Results:
High versus low-dose dexamethasone for postoperative anagesia after caesarean section: a randomised, double-blind, two-center study.
|
Summary
|
|
EudraCT number |
2020-005681-33 |
Trial protocol |
BE |
Global end of trial date |
31 Dec 2022
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
22 May 2024
|
First version publication date |
22 May 2024
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
MVDVER102020
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
University Hospitals Leuven, Department of Anesthesiology
|
||
Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
|
||
Public contact |
Department of Anesthesiology, University Hospitals Leuven, +32 16344270, marc.vandevelde@uzleuven.be
|
||
Scientific contact |
Department of Anesthesiology, University Hospitals Leuven, +32 16344270, marc.vandevelde@uzleuven.be
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
26 Apr 2023
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
31 Dec 2022
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
31 Dec 2022
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The objective of this trial is that the addition of high-dose dexamethasone 25 mg twice (at day 0 and day 1 after surgery) to multimodal analgesia (paracetamol and NSAIDs combined with a single-shot local anesthetic wound infiltration) will result in more effective analgesia and better patient functionality the first 48 hours following Caesarean section compared with a standard 5-mg dose.
|
||
Protection of trial subjects |
Yes
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Feb 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belgium: 210
|
||
Worldwide total number of subjects |
210
|
||
EEA total number of subjects |
210
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
210
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
If eligible, a convenience sample of patients (when the investigators were available) were approached the day of cesarean section prior to surgery and given verbal and written information. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Inclusion criteria: elective CS scheduled with neuraxial anesthesia, > 36 weeks of gestation, and ASA physical status II. Exclusion criteria: labor, ASA physical status III and IV, known allergies to the study drugs, diabetes, chronic use of corticosteroids or opioids, antepartum administration of corticosteroids, peptic ulcers, <18yrs of age | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Study period (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
Random allocation was performed using a computer-generated permuted block randomization list stratified on study site (variable block-size with 1:1 allocation). Allocation concealment was achieved using sequentially numbered opaque sealed envelopes containing group assignments. An anesthetist or midwife not involved in patient management or data collection opened the envelope before surgery and prepared the study medication
|
|||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
High-dose dexamethasone | |||||||||
Arm description |
2 x 25 mg of dexamethasone | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
dexamethasone
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Concentrate for solution for injection
|
|||||||||
Routes of administration |
Intravenous bolus use
|
|||||||||
Dosage and administration details |
25 mg dexamethasone in 100 ml saline bag
|
|||||||||
|
Arm title
|
Low-dose dexamethasone | |||||||||
Arm description |
1 x 5mg of dexamethasone | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||
|
||||||||||
|
|||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
High-dose dexamethasone
|
||
Reporting group description |
2 x 25 mg of dexamethasone | ||
Reporting group title |
Low-dose dexamethasone
|
||
Reporting group description |
1 x 5mg of dexamethasone | ||
|
|||||||||||||
End point title |
primary outcome | ||||||||||||
End point description |
the cumulative pain score with movement from 4 to 48 hours after CS assessed with area under the NRS score x time curve (AUC
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
from 4 to 48 hours after CS
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis | ||||||||||||
Comparison groups |
High-dose dexamethasone v Low-dose dexamethasone
|
||||||||||||
Number of subjects included in analysis |
210
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
untill 8 weeks after Cesarean section
|
|||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
|
|||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
High-dose dexamethasone
|
|||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Low-dose dexamethasone
|
|||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
