Clinical Trial Results:
Does perineural dexmedetomidine prolong the duration of an adductor canal block
when controlling for a systemic effect?
- a randomized, blinded, paired study in healthy volunteers
Summary
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EudraCT number |
2014-005651-89 |
Trial protocol |
DK |
Global end of trial date |
09 Sep 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Dec 2021
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First version publication date |
22 Dec 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 |
SM2-JH-2014
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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 |
Zealand University Hospital
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Sponsor organisation address |
Lykkebækvej 1, Koege, Denmark, 4600
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Public contact |
Clinical trials information, Køge Sygehus, 0045 60610666, hessel@dadlnet.dk
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Scientific contact |
Clinical trials information, Køge Sygehus, 0045 60610666, hessel@dadlnet.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 |
01 Oct 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Sep 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Sep 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 investigate whether dexmedetomidine as an adjuvant to ropivacaine for
adductor canal block increases duration of the sensory block when
controlling for a systemic effect
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Protection of trial subjects |
All nerve blocks were
performed by a trained anesthesiologist
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2015
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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: 42
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Worldwide total number of subjects |
42
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EEA total number of subjects |
42
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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) |
42
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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 |
PAtients very healthy volunteers recruited in the medical School of Copenhagens medical bulletin. | |||||||||
Pre-assignment
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Screening details |
Eligible volunteers were males, more than 18 years old, and had American Society of Anesthesiologists physical status I. Exclusion criteria were inability to read and speak Danish, allergies to the involved drugs, weekly alcohol consumption of more than 21 units, medical abuse, use of any analgesics within 48 h or consumption of opioids within | |||||||||
Period 1
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Period 1 title |
baseline
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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, Monitor, Data analyst, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ropi + dex | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Dexmedetomidine
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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 |
Perineural use
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Dosage and administration details |
100ug perineurally
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Arm title
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Ropi + placebo | |||||||||
Arm description |
- | |||||||||
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 |
Injection
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Routes of administration |
Perineural use
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Dosage and administration details |
1ml
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Period 2
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Period 2 title |
overall trial
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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, Monitor, Data analyst, Subject, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ropi + placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
ropivacaine
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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 |
Perineural use
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Dosage and administration details |
150mg
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Arm title
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Ropi + dex | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Dexmedetomidine
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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 |
Perineural use
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Dosage and administration details |
100ug
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Baseline characteristics reporting groups
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Reporting group title |
baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ropi + dex
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Reporting group description |
- | ||
Reporting group title |
Ropi + placebo
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Reporting group description |
- | ||
Reporting group title |
Ropi + placebo
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Reporting group description |
- | ||
Reporting group title |
Ropi + dex
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Reporting group description |
- |
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End point title |
duration of sensory nerve block assessed by temperature discrimination | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0-48h
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Statistical analysis title |
paired t test | ||||||||||||
Statistical analysis description |
paired t test
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Comparison groups |
Ropi + placebo v Ropi + dex
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
duration of sensory nerve block assessed by pinprick | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-48h
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No statistical analyses for this end point |
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End point title |
duration of sensory nerve block assessed pain during tonic heat stimulation | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-48h
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No statistical analyses for this end point |
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End point title |
duration of nerve block assessed by warmth detection threshold | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-48h
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No statistical analyses for this end point |
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End point title |
duration of sensory nerve block assessed by heat pain detection threshold | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-48
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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 |
0-48 h
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Assessment type |
Non-systematic | ||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
all participants
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Reporting group description |
- | ||||||||||||||||
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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. | |||
None reported |