Clinical Trial Results:
The FINOF(Femoral Nerve-Block Intervention in Neck Of Femur Fracture) Study
Summary
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EudraCT number |
2010-023871-25 |
Trial protocol |
GB |
Global end of trial date |
05 Jan 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2017
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First version publication date |
06 Jan 2017
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Other versions |
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Summary report(s) |
End of Study Report |
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 |
2010-023871-25
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Nottingham University Hospitals NHS Trust
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Sponsor organisation address |
Derby Road, Nottingham, United Kingdom, NG7 2UH
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Public contact |
Maria Koufali, Nottingham Univeristy Hospitals NHS Trust, researchsponsor@nuh.nhs.uk
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Scientific contact |
Maria Koufali, Nottingham Univeristy Hospitals NHS Trust, researchsponsor@nuh.nhs.uk
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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 |
05 Jan 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Jan 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jan 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 |
The question to be asked is whether femoral nerve blockade, administered in the acute and early post operative phase to elderly hip fracture patients, will control pain,improve early rehabilitation and reduce opioid associated complications.
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Protection of trial subjects |
The study received ethical approval on 28/Jan/2011 from Nottingham Research Ethics Committee 2 and by the MHRA on 21/Apr/2011.
To facilitate rapid analgesia patients were consented as a two stage procedure. Patients were provided with the patient information sheet and the study was discussed. Initial verbal consent was obtained in the ED by the attending anaesthetist. This was witnessed by a member of the research team and documented. Full written consent was obtained 48 hours after verbal consent or as close as this as possible. Patients who developed confusion after study entry and were unable to give written cosnent had proxy consent sought from the lsited next of kin or contact person. If no primary contact person could be found the orthopaedic consultant in charge of the patients care was approached. Once patients had regained capacity, formal written consent was sought as per usual study procedure.
Participants were monitored for AEs and SAEs and these were reported as per the sponsor SOP.
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Background therapy |
In addition to the IMP (Femoral Nerve block) the active group received regular paracetamol with oral morphine for breakthrough analgesia. They also had a femoral nerve catheter which infused 5mls/hr of 0.2% ropivacaine via an elastomeric pump. In addition to the control treatment, the control group received regular paracetamol and regular tramadol with oral morphine solution every 2 hours as required for breakthrough pain. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Jan 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 |
United Kingdom: 111
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Worldwide total number of subjects |
111
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EEA total number of subjects |
111
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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 |
60
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85 years and over |
51
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Recruitment
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Recruitment details |
Recruitment started on 6th Jan 2011 and the last participant was screened on 1st Dec 2014 | ||||||||||||
Pre-assignment
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Screening details |
Patients presenting with history suggestive of proximal femoral fracture were attended and inclusion/exclusion criteria were checked. If patients were eligible then initial verbal consent was obtained. | ||||||||||||
Period 1
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Femoral Nerve Block | ||||||||||||
Arm description |
Femoral nerve block followed by insertion of a femoral catheter and continuous femoral nerve block | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Levo-bupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
0.5 ml/kg-1 of 0.25% levobupivacaine up to 30 ml maximum volume
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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 |
5ml/hr 0.2% ropivacaine for up to 48 hours post-operatively
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Arm title
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Control | ||||||||||||
Arm description |
Standard analgesic care - intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below. | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Morphine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
Intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below.
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Baseline characteristics reporting groups
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Reporting group title |
Femoral Nerve Block
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Reporting group description |
Femoral nerve block followed by insertion of a femoral catheter and continuous femoral nerve block | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
Standard analgesic care - intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Full primary outcome data was collected on a total of 111 patients (55 active, 56 control).
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End points reporting groups
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Reporting group title |
Femoral Nerve Block
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Reporting group description |
Femoral nerve block followed by insertion of a femoral catheter and continuous femoral nerve block | ||
Reporting group title |
Control
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Reporting group description |
Standard analgesic care - intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below. | ||
Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Full primary outcome data was collected on a total of 111 patients (55 active, 56 control).
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End point title |
Cumulative Ambulation Score | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Three days, post-operative
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Statistical analysis title |
p-value | |||||||||
Comparison groups |
Femoral Nerve Block v Control
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Number of subjects included in analysis |
111
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.76 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
Cumulative Dynamic pain score | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
three days post-operative
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Statistical analysis title |
p-value | |||||||||
Comparison groups |
Femoral Nerve Block v Control
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Number of subjects included in analysis |
111
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.505 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
All AEs occurring during the study observed by the investigator or reported by the participant, whether or not attributed to study medication, will be recorded on the CRF.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
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Reporting groups
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Reporting group title |
Control
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Reporting group description |
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Reporting group title |
Active
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 May 2011 |
1) Use of pump changed to continue for 48 hours after operation
2) Additional block assessments to be performed at 60 min and 180 min post operatively
3) Dynamic pain assessments clarified; to be performed at 30 min, 60 min and 180 min post block
4) Clarification that a continuous infusion of local anaesthetic will be given for 48 hours post operatively
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21 Dec 2011 |
The type of pump changed from Accufusor to Elastomeric to allow generic pumps. |
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27 Sep 2013 |
1) Follow up duration amended to 30(±5) days to give more flexibility
2) Clarification that cumulative dynamic pain scores are performed preoperatively (at 30 mins, 180 mins and following the initial femoral nerve block)
3) Changed to state that daily calorific intake and bowels (frequency and type) are not collected at pre-op
4) Assessment of nausea and vomiting clarified to ensure it matches the actual data collected and scoring system used in the CRF
5) Other typographical changes and changes to timelines.
6) Clarification of duration of catheter insertion and use of Oramorph which is standard practice on wards.
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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. | |||
Not all data was available to the results uploader so although 141 participants were enrolled, data from withdrawn patients has not been included in the database, therefore some information has been omitted for validation purposes. |