Clinical Trial Results:
A randomized trial of automated intermittent ropivacaine administration vs. continuous infusion in an interscalene catheter
Summary
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EudraCT number |
2013-000235-27 |
Trial protocol |
DK |
Global end of trial date |
22 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Mar 2021
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First version publication date |
25 Mar 2021
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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 |
2013-000235-27
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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 |
Odense Universitets hospital
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Sponsor organisation address |
J. B. Winsløws Vej 4, Odense, Denmark, 5000
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Public contact |
Dep. V, Odense University Hospital, 45 66113333,
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Scientific contact |
Dep. V, Odense University Hospital, 45 66113333,
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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 |
04 Apr 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Mar 2015
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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 |
To investigater wether we can reduce pain associated with shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection
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Protection of trial subjects |
Written informed consent was obtained from all subjects before enrollment. The investigators performed this.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Feb 2013
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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: 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) |
20
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From 65 to 84 years |
40
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85 years and over |
0
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Recruitment
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Recruitment details |
Written informed consent was obtained from all subjects before enrollment. The investigators performed this. | ||||||
Pre-assignment
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Screening details |
Patients were recruited in the Department of Orthopedic Surgery, Odense University Hospi- tal, Denmark. Inclusion criteria: Adult patients (aged ≥ 18 years, ASA 1-3) undergoing major shoulder surgery performed under general anesthesia with continuous inter- scalene nerve block. | ||||||
Pre-assignment period milestones
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Number of subjects started |
35 [1] | ||||||
Number of subjects completed |
35 | ||||||
Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 10 more patients were enrolled to ensure statistical significance |
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Period 1
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Period 1 title |
Study 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, Data analyst, Carer, Assessor | ||||||
Arms
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Arm title
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intervention | ||||||
Arm description |
ropivacain administation | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
ropivacain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for suspension for injection
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Routes of administration |
Infiltration
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Dosage and administration details |
2mg/ml 16ml/t
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Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 10 more patients were enrolled to ensure statistical significance |
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Period 2
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Period 2 title |
intervention
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Is this the baseline period? |
No | ||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||
Roles blinded |
Investigator, Data analyst, Carer, Assessor, Subject | ||||||
Arms
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Arm title
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intervention | ||||||
Arm description |
control | ||||||
Arm type |
Placebo | ||||||
Investigational medicinal product name |
saline
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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 |
Infiltration
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Dosage and administration details |
16ml/t
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Baseline characteristics reporting groups
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Reporting group title |
Study period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
control
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
placebo was administered (saline)
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Subject analysis set title |
intervention
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
ropivacain
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End points reporting groups
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Reporting group title |
intervention
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Reporting group description |
ropivacain administation | ||
Reporting group title |
intervention
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Reporting group description |
control | ||
Subject analysis set title |
control
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
placebo was administered (saline)
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Subject analysis set title |
intervention
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
ropivacain
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End point title |
VAS [1] | ||||||||||
End point description |
VAS score from 1-10
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End point type |
Primary
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End point timeframe |
Through out the study period
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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: due to technical complication it was not possible to assign a statistical analysis it can be viewed en the article |
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No statistical analyses for this end point |
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End point title |
morphine | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
through out the study
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Through out the study
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Adverse event reporting additional description |
one patient experienced a lung embolism during the study period.
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Assessment type |
Systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Danish medcal center | ||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
study group
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Reporting group description |
included patients | ||||||||||||||||||||||
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: This is right |
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||
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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. | |||
VAS might not be the best measure for effect | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29034961 |