Clinical Trial Results:
Preoperative analgesic affect of combined obturator and femoral nerve block compared to femoral nerve block alone, in patients with hip fracture.
Summary
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EudraCT number |
2015-002304-89 |
Trial protocol |
DK |
Global end of trial date |
09 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Jan 2021
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First version publication date |
19 Jan 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 |
protocol2_2tdn
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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 |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus, Denmark, 8200
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Public contact |
Dep. Anaesthesia, Aarhus University Hospital, +45 51542997, tfbe@clin.au.dk
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Scientific contact |
Dep. Anaesthesia, Aarhus University Hospital, +45 51542997, tfbe@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 |
09 Aug 2018
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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 |
09 Aug 2018
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The objective of the trial is to investigate if the combination af a femoral and a obturator nerve block provides better analgesia that a femoral nerve block alone, in patients with hip fracture
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Protection of trial subjects |
This trial was conducted in accordance with the Declaration of Helsinki and approved by the Danish Medicines Agency, the Central Denmark Region Commitees on Health Research Ethics. The trial was prospectively registered in the Eudra database and monitored by the Good Clinical Practice Unit at Aalborg and Aarhus University Hospitals. Prior to inclusion written informed consent was obtained from all subject after a thorough oral and written information had been given.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Aug 2015
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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: 26
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Worldwide total number of subjects |
26
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EEA total number of subjects |
26
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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) |
0
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From 65 to 84 years |
11
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85 years and over |
15
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Recruitment
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Recruitment details |
Patients were recruited at Aarhus University Hospital according to the approved recruitment plan in the protocol. | |||||||||
Pre-assignment
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Screening details |
INCLUSION: Suspected hip fracture, age > 54 years, able to follow instructions according to the protocol, arrival to ER at hours where involved anesthesiologists are present, NRS pain score > 3 at rest and > 5 during dynamic examination EXCLUSION: No hip fracture at X-ray, weight < 40 kg, allergy to local anesthetics, infection in hip area | |||||||||
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, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Active obturator nerve block | |||||||||
Arm description |
Femoral nerve block with 15 mL bupivacaine 0.25% + obturator nerve block with 20 mL bupivacaine 0.25% | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Bupivacaine 0.25%
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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 |
Femoral nerve block with 15 mL and obturator nerve block with 20 mL.
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Arm title
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Placebo obturator nerve block | |||||||||
Arm description |
Active femoral nerve block and placebo obturator nerve block | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Bupivacaine 0.25%
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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 |
Femoral nerve block with 15 mL
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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 |
Obturator nerve block with 20 mL
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Notes [1] - 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: 26 patients were enrolled - 13 patients were excluded before randomization due to the exclusion criteria defined in the protocol. |
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
26 patients were enrolled - only 13 completed randomization. 13 were excluded before randomization according to the exclusion criteria defined in the protocol. | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Active obturator nerve block
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Reporting group description |
Femoral nerve block with 15 mL bupivacaine 0.25% + obturator nerve block with 20 mL bupivacaine 0.25% | ||
Reporting group title |
Placebo obturator nerve block
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Reporting group description |
Active femoral nerve block and placebo obturator nerve block |
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End point title |
Succesrate for sufficient analgesia 30 min after nerve block | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
30 min after nerve block
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Statistical analysis title |
Success of obturator nerve block | |||||||||||||||
Comparison groups |
Placebo obturator nerve block v Active obturator nerve block
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Number of subjects included in analysis |
13
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.05 | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
30 minutes after obturator nerve block
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Assessment type |
Non-systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
All subjects enrolled
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Reporting group description |
- | ||||||||||||||||||||||
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: No non-serious adverse events occurred. The trial was terminated prematurely and therefore only 26 patients were enrolled and only 13 patients were randomized. One serious adverse event occurred but this adverse event was not related to the trial medication because it occurred after femoral nerve block and before randomization and obturator nerve block. |
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Frequency threshold for reporting non-serious adverse events: 0.05% | |||||||||||||||||||||||
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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? Yes | |||||||
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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 |