Clinical Trial Results:
Dorsal penile nerve block(DPNB) for circumcision: a comparison of ultrasound-guided vs. landmark technique.
Summary
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EudraCT number |
2012-001217-16 |
Trial protocol |
BE |
Global end of trial date |
30 Nov 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Dec 2019
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First version publication date |
30 Dec 2019
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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 |
AT032012
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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 |
University Hospitals Leuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium,
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Public contact |
Anesthesie Research, UZLeuven, 0032 016344620, christel.huygens@uzleuven.be
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Scientific contact |
Anesthesie Research, UZLeuven, 0032 016344620, christel.huygens@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 |
20 Dec 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2016
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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 |
confirming the hypothesis that the US-guided Dorsal penile nerve block will provide better and longer postoperative analgesia in circumcision patients when compared to the landmark technique.
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Protection of trial subjects |
All patients received paracetamol for pain treatment intraoperatively.
Pain scores were measured frequently
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2012
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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: 310
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Worldwide total number of subjects |
310
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EEA total number of subjects |
310
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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) |
132
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Children (2-11 years) |
178
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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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 |
- | |||||||||
Pre-assignment
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Screening details |
Children between 52 weeks podtconception and 11 years , ASA 1-2 undergoing elctive circumcision | |||||||||
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 |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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LM-DPNB | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
levobupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Infiltration
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Dosage and administration details |
0.1ml/kg at both sides into the subpubic space
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Arm title
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US-DPNB | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
levobupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Infiltration
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Dosage and administration details |
0.1ml/kg at both sides into the subpubic space
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
LM-DPNB
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
primary outcome
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Subject analysis set title |
US-DPNB
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
primary outcome
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End points reporting groups
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Reporting group title |
LM-DPNB
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Reporting group description |
- | ||
Reporting group title |
US-DPNB
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Reporting group description |
- | ||
Subject analysis set title |
LM-DPNB
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
primary outcome
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Subject analysis set title |
US-DPNB
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
primary outcome
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End point title |
number of patients needing piritramide postoperatively | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
postoperatively until discharge
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Statistical analysis title |
need for piritramide postoperatively | |||||||||
Comparison groups |
LM-DPNB v US-DPNB
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Number of subjects included in analysis |
310
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Intraoperatively and postoperatively until 24 hours
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Assessment type |
Systematic | ||
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% | |||
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: All patients were observed for adverse during the first 24 hours postoperatively. No technique related adverse events were 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 |