Clinical Trial Results:
Regional anaesthesia of the cutaneous nerves of the hip -
A novel ultrasound guided nerve block of the superior cluneal nerves
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Summary
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EudraCT number |
2016-004541-82 |
Trial protocol |
DK |
Global end of trial date |
22 Jan 2017
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Results information
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Results version number |
v2(current) |
This version publication date |
25 Jan 2021
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First version publication date |
02 Jan 2021
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Other versions |
v1 |
Version creation reason |
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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 |
SupClun_1-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
Dep. Anaesthesia and Intensive Care, Aarhus University Hospital, +45 28782877, thomas.dahl.nielsen@clin.au.dk
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Scientific contact |
Dep. Anaesthesia and Intensive Care, Aarhus University Hospital, +45 28782877, thomas.dahl.nielsen@clin.au.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 |
15 Feb 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Jan 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Jan 2017
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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 evaluate the success of a nerve block of the superior cluneal nerves (SupClun) in
producing cutaneous anaesthesia posterior to - and continous with - the area of anesthesia produced by the lateral femoral cutaneous nerve (LFCN) block and the Transversalis Fascia Plane (TFP) block
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Protection of trial subjects |
This volunteer trial was conducted in accordance with the declaration of Helsinki and approved by the Danish Medicines Agency, the Central Denmark Region Committees on health research ethics and the Danish Data Protection Agency. The trial was prospectively registered in the EudraCT database and was monitored by the Good Clinical Practice Unit at Aalborg and Aarhus University Hospitals. Prior to inclusion written informed consent was obtained from all subjects after thorough oral and written participant information had been given.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2017
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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 |
Denmark: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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 |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Healthy volunteers of 18 years or older were recruited through a Danish website dedicated to recruit volunteers for research. All volunteers received payment for their participation. | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: Age ≥ 18 years; Written informed consent; Healthy (ASA I-II); Able to cooperate; Understand and speak Danish Exclusion criteria: Reduced cutaneous sensibility; anatomy/psychological impediment of participation; allergy to local anesthetics; pregnancy; weight below 65 kg; infection at the site of injection | |||||||||
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Period 1
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Period 1 title |
Overall 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, Monitor, Data analyst, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Active | |||||||||
Arm description |
15 mL ropivacaine 3.75 mg/mL for superior cluneal nerve block | |||||||||
Arm type |
Experimental | |||||||||
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 |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
15 mL 3.75 mg/mL
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Arm title
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Placebo | |||||||||
Arm description |
Isotonic saline 15 mL for superior cluneal nerve block. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Sodium chloride 0.9%
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Investigational medicinal product code |
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Other name |
Isotonic saline
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
15 mL isotonic saline for superior cluneal nerve block.
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Active
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Reporting group description |
15 mL ropivacaine 3.75 mg/mL for superior cluneal nerve block | ||
Reporting group title |
Placebo
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Reporting group description |
Isotonic saline 15 mL for superior cluneal nerve block. | ||
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End point title |
Success rate of superior cluneal nerve block | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pinprick before and 45 min after superior cluneal nerve block
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Statistical analysis title |
Success rate of superior cluneal nerve block | |||||||||||||||
Comparison groups |
Active v Placebo
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
< 0.001 | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
60 minutes after placement of the last nerve block
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
10.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| 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 was a volunteer study including healthy young volunteers and the interventions were extremely low risk. |
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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 | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/31061111 |
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