Clinical Trial Results:
A dose finding study for ultrasound guided anterior psoas compartment blocks in patients with a fractured neck of femur
Summary
|
|
EudraCT number |
2009-013462-25 |
Trial protocol |
GB |
Global end of trial date |
04 Apr 2011
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
04 Apr 2019
|
First version publication date |
04 Apr 2019
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
GN09AN334
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00926666 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
NHS Greater Glasgow and Clyde Health Board
|
||
Sponsor organisation address |
Dalnair Street, Glasgow, United Kingdom, G3 8SJ
|
||
Public contact |
Dr Malcolm Watson, NHS Greater Glasgow and Clyde, 0044 141 452 3430, Malcolm.Watson@ggc.scot.nhs.uk
|
||
Scientific contact |
Dr Malcolm Watson, NHS Greater Glasgow and Clyde, 0044 141 452 3430, Malcolm.Watson@ggc.scot.nhs.uk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
04 Apr 2011
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
04 Apr 2011
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
04 Apr 2011
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Can we reduce the dose of local anaesthetic required to provide pain relief to patients with a broken hip by determining the dose based on the amount of the drug required to relieve pain?
|
||
Protection of trial subjects |
All patient recruited to this study received standard analgesia and anaesthesia for a emergency hip arthroplasty or fixation.
The only variable was the concentration of local anaesthetic used to provide an anterior psoas compartment block.
All peripheral nerve blocks have an associated risk. The commonest complication was peripheral neuropathy and the vast majority of these neuropathies were not present after 6 months.
The sighting of an anterior psoas compartment block (femoral nerve block) is considered to have an acceptable risk benefit ratio for elective and emergency hip and knee arthroplasty in current clinical practice.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 40
|
||
Worldwide total number of subjects |
40
|
||
EEA total number of subjects |
40
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
40
|
||
85 years and over |
0
|
|
|||||||||||
Recruitment
|
|||||||||||
Recruitment details |
40 patients recruited from 1st Feb 2010 to 17th Nov 2010 Patients with a traumatic proximal femoral fracture scheduled for surgical hip fixation were recruited. | ||||||||||
Pre-assignment
|
|||||||||||
Screening details |
Potential recruits to the study were identified by the nursing and medical staff of the orthopaedic trauma ward. | ||||||||||
Period 1
|
|||||||||||
Period 1 title |
Trial (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
|
||||||||||
Blinding used |
Not blinded | ||||||||||
Arms
|
|||||||||||
Arm title
|
Arm A and B | ||||||||||
Arm description |
Part A - A single 30ml dose of levobupivacaine with the dose concentration increased following an unsuccessful anterior psoas compartment block and decreased following an effective anterior psoas compartment block. Part B - To estimate the duration of analgesia provided by the EC95 concentration of levobupivacaine estimated to provide ≥10 hours of analgesia from part A of this clinical trial and to determine if the peak plasma levobupivacaine concentrations are within safe limits. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
levobupivacaine
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Solution for injection
|
||||||||||
Routes of administration |
Perineural use
|
||||||||||
Dosage and administration details |
Part A - The first 16 patients were treated with a starting concentration of 0.1% and the concentration was decreased or increased by 0.025% depending on whether the previous dose was effective or not.
In part B the dose will be the same for all patients (calculated from the results of part A).
|
||||||||||
|
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Arm A and B
|
||
Reporting group description |
Part A - A single 30ml dose of levobupivacaine with the dose concentration increased following an unsuccessful anterior psoas compartment block and decreased following an effective anterior psoas compartment block. Part B - To estimate the duration of analgesia provided by the EC95 concentration of levobupivacaine estimated to provide ≥10 hours of analgesia from part A of this clinical trial and to determine if the peak plasma levobupivacaine concentrations are within safe limits. |
|
|||||||||
End point title |
Part A - Primary Outcome [1] | ||||||||
End point description |
EC50 and EC95 concentrations of 30mls of levobupivacaine for ≥10hours of analgesia after a femoral 3-in-1 nerve block.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
From 3 in 1 nerve block administration to 24 hours post
|
||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Details of the statistical analysis performed are within CIs PhD published. Results uploader not involved in study at all. |
|||||||||
|
|||||||||
Attachments |
Part A Primary Endpoint |
||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B - Primary Outcome [2] | ||||||||
End point description |
To estimate the duration of analgesia provided by the EC95 concentration of levobupivacaine estimated (using probit logistic regression analysis) to provide ≥10 hours of analgesia from part A of this clinical trial and to determine if the peak plasma levobupivacaine concentrations are within safe limits.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve block administration to 24 hours
|
||||||||
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Details of the statistical analysis performed are within CIs PhD published. Results uploader not involved in study at all. |
|||||||||
|
|||||||||
Attachments |
Part B - Primary Endpoint |
||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
Adverse events information [1]
|
|||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
A - From discharge from theatre, events were only reported and recorded if they are causally related to the anterior psoas compartment nerve block.
B - Adverse events occurring after the final pain scores are recorded (up to 24 hours later).
|
||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
1
|
||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Serious Adverse Events
|
||||||||||||||||||||||||||||||
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: These were not collected |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
18 Aug 2010 |
1 prolongation of the maximum storage period of the IMP between preparation (by the pharmacy production unit) and patient administration,
2 the insertion of a catheter after injection of the IMP to allow continued pain relief,
3 a broadening of the inclusion criteria to include patients with proximal femoral fractures who will be managed non-surgically and patients with fractures of the femur around hip implants,
4 a reduction in the IMP minimum dose to allow accurate estimation of the minimum effective concentration of levobupivacaine in 50% of patients.
5 an improvement in the layout of the CRF form,
6 a change in the way data from the trial will be analysed, which will not affect the primary end point,
7 storage of the CRF (change of site due to building work),
8 details on the biochemical analysis of the blood samples taken in the second part of the study to determine the levels of drug in the blood.
|
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |