Clinical Trial Results:
Effect of a lateral nerve of the thigh block on postoperative pain after total hip replacement surgery: a clinical radomised trial.
Summary
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EudraCT number |
2013-004501-12 |
Trial protocol |
DK |
Global end of trial date |
01 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Aug 2017
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First version publication date |
16 Aug 2017
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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 |
001-2013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02289937 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Departement of Anesthesiology, Næstved Hospital
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Sponsor organisation address |
Ringstedgade 61, Næstved, Denmark, 4700
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Public contact |
Daniel Hägi-Pedersen, Departement of Anesthesiology, Næstved Hospital, +45 56514792, dhag@regionsjaelland.dk
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Scientific contact |
Daniel Hägi-Pedersen, Departement of Anesthesiology, Næstved Hospital, +45 56514792, dhag@regionsjaelland.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 |
20 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 2014
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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 |
Investigation of the influence of a lateral cutaneus nerve of the thigh block on postoperative pain after total hip replacement surgery with visual analog scale and on the total oxynorm dose 1. day after surgery.
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Protection of trial subjects |
Treated with usual care.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Mar 2014
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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: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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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) |
25
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From 65 to 84 years |
71
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85 years and over |
4
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
All patients planned for primary total hip replacement | |||||||||
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 |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ropivacaine | |||||||||
Arm description |
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ropivacaine
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Investigational medicinal product code |
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Other name |
naropin
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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 |
60 milligrams
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Arm title
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Placebo | |||||||||
Arm description |
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided | |||||||||
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 |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
8 milliliters
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End points reporting groups
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Reporting group title |
Ropivacaine
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Reporting group description |
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided. | ||
Reporting group title |
Placebo
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Reporting group description |
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided |
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End point title |
VAS-score 4 hours postoperative during movement | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
4 hours postoperative
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Statistical analysis title |
Mann-Withney-U-Test | ||||||||||||
Comparison groups |
Ropivacaine v Placebo
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Oxycodone consumed the first 24 h | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-24 hours postoperatively
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No statistical analyses for this end point |
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End point title |
Time to first oxynorm requirement | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-24 hours postoperatively
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No statistical analyses for this end point |
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End point title |
Cumulated ambulation score the first day | ||||||||||||
End point description |
Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
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End point type |
Secondary
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End point timeframe |
0-24 hours postoperatively
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No statistical analyses for this end point |
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End point title |
Time from surgery to first ambulation | ||||||||||||
End point description |
Time to first mobilization
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End point type |
Secondary
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End point timeframe |
0-24 hours postoperatively
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No statistical analyses for this end point |
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End point title |
Length of hospital stay | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0-7 days postoperative
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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 |
0-24 hours postoperatively
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
ICH Guideline | ||
Dictionary version |
E6
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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: Only adverse events related to the study medication were included. |
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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/27006014 |