Clinical Trial Results:
postoperative effect of optimal multimodal pain management supplemented with systemic single dose of Dexamethason in the first week after UKA. Low dose (8mg) or mean dose
Summary
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EudraCT number |
2017-003003-22 |
Trial protocol |
DK |
Global end of trial date |
12 Oct 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Jan 2022
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First version publication date |
19 Jan 2022
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Other versions |
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 |
N-20170060
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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 |
Northern Ortopaedic Division
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Sponsor organisation address |
Barfredsvej 83, Frederikshavn, Denmark, 9900
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Public contact |
Frederikshavn Sygehus, Ortopedic Department, Aalborg University Hospital, +45 22851102, m.brouw@rn.dk
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Scientific contact |
Frederikshavn Sygehus, Ortopedic Department, Aalborg University Hospital, +45 22851102, m.brouw@rn.dk
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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 |
12 Oct 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Oct 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Oct 2021
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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 |
Pain management i the first week after UKA
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Protection of trial subjects |
All subjects had acess to escape pain-killers
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 90
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Worldwide total number of subjects |
90
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EEA total number of subjects |
90
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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) |
44
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From 65 to 84 years |
46
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment period: 01.01.2018 till 01.10.2019. North Jutland Region, Denmark | ||||||||||||
Pre-assignment
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Screening details |
Recruitment period: 01.01.2018 till 01.10.2019. North Jutland Region, Denmark. Patients referred from GP to hospital with knee pains were screened. Patients without need for surgical interventions were excluded. | ||||||||||||
Period 1
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Period 1 title |
Study period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
No blinding
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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8 mg | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
8 mg dexamethasone administered I.V. immediately before surgery.
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Arm title
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16 mg | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for infusion
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Routes of administration |
Injection
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Dosage and administration details |
16 mg dexamethasone administered I.V. immediately before surgery.
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Arm title
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24 mg | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
24 mg dexamethasone administered I.V. immediately before surgery.
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Baseline characteristics reporting groups
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Reporting group title |
8 mg
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
16 mg
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
24 mg
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
8 mg
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Reporting group description |
- | ||
Reporting group title |
16 mg
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Reporting group description |
- | ||
Reporting group title |
24 mg
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Reporting group description |
- |
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End point title |
Mean NRS pain 2 days post Surgery | ||||||||||||||||
End point description |
Mean NRS pain in activity
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End point type |
Primary
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End point timeframe |
2 days after surgery
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Attachments |
Mean NRS during activity |
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Statistical analysis title |
Kruskal-Wallis equality-of-populations rank test | ||||||||||||||||
Statistical analysis description |
Mean NRS pain during activity
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Comparison groups |
8 mg v 16 mg v 24 mg
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
Kruskal-wallis | ||||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
01-01-2018 til 12-10-2021
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
GCP unit | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 1% | |||
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: We did not record any adverse events. |
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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 |