Clinical Trial Results:
Procedures of locoregional analgesia and quality of life in palliative care units.
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Summary
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EudraCT number |
2009-016701-42 |
Trial protocol |
FR |
Global end of trial date |
22 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
28 May 2021
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First version publication date |
28 May 2021
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Other versions |
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Summary report(s) |
2009-016701-42_results |
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 |
I08014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01094912 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CHU de Limoges
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Sponsor organisation address |
2 Avenue Martin Luther King, Limoges, France,
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Public contact |
A BENTALEB, CHU de LImoges, 33 555058616, abdeslam.bentaleb@chu-limoges.fr
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Scientific contact |
A BENTALEB, CHU de LImoges, 33 555058616, abdeslam.bentaleb@chu-limoges.fr
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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 |
22 Mar 2016
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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 |
22 Mar 2016
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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 |
This is a multicenter, interventional study in adult cancer patients with unrelenting mixed pain (nociceptive and neuropathic), for which conventional oral or parenteral treatments have been shown to be ineffective or insufficient.
The main objectif is to valuate the improvement of the quality of life for patients using the 15th item of the EORTC QLQ-C15-PAL questionnary, a week after the introduction of an analgesia
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
All the patients gave their consent after information and explanation of the research. After initial pain assessment, each patient receives a test injection. If the test is positive (reduction or disappearance of painful phenomena in the offending territory), a continuous administration system is set up.
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Background therapy |
Common products were Chirocaine, morphine hydrochloride and are administered following a precise medical prescription: from 2 to 4 ml / h of Chirocaine at 2.5 mg / ml for peri-nerve blocks; 4 ml / h of Chirocaine at 2.5 mg / ml for epidurals and 0.1 mg of morphine hydrochloride for spinal anesthesia associated with 2 ml of Chirocaine at 2.5 mg / ml every 12 hours. The injections are repeated according to the variation in pain, respecting the limits of the SPCs. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jul 2010
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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 |
France: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
8
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were recruit at the palliatve department at Limoges University Hospital and Bordeaux University Hospital. | ||||||||||||
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Pre-assignment
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Screening details |
Patient ≥ 18 years-old, with untreatable cancer, hospitalized in a palliative care unit, with a life expectancy ≥ 1 week and pain unresponsive to conventional treatments | ||||||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Locoregional anesthesia | ||||||||||||
Arm description |
According to pain location, the procedures could be epidural analgesia, rachianesthesia, or continuous nerve blocks. They will be performed only if the injection test is positive. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Chirocaïne®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradural use
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Dosage and administration details |
2 - 4 ml/h de Chirocaïne (2,5 mg/ml) for pour les blocs péri nerveux ;
4 ml/h de Chirocaïne à 2,5 mg/ml pour les péridurales
à 2ml de Chirocaïne à 2,5 mg/ml toutes les 12 heures for la rachianesthésie
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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 |
Injection
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Routes of administration |
Intratracheal use
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Dosage and administration details |
0,1 mg for naif patients or ou 1/200e of the day dose for patients rceiving morphine.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Locoregional anesthesia
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Reporting group description |
According to pain location, the procedures could be epidural analgesia, rachianesthesia, or continuous nerve blocks. They will be performed only if the injection test is positive. | ||
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End point title |
Comparison of EORTC-QLQ15 PAL element 15 one week before and one week after analgesia device implementation [1] | ||||||||
End point description |
The main analysis consisted of a paired comparison of the mean score of item 15 of the EORTC QLQ-C15-PAL (on a scale of 0 to 100) assessed before implementation of locoregional analgesia and one week after. The comparison was carried out using a paired Student's test
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End point type |
Primary
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End point timeframe |
1 Week after analgesia device implementation
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| 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: Main analysis consisted in paired comparison of mean score for item 15 of EORTC QLQ-C15-PAL between baseline and one week after treatment. Comparison used StudentStudent paired t test or Wilcoxon paired test, depending on respect of application conditions |
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| No statistical analyses for this end point | |||||||||
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End point title |
Physical function score | ||||||||
End point description |
Analysis of the change in EORTC-15PAL sub-scores between one week before the establishment of locoregional analgesia and one week after.
This score is calculated from the first 03 items of EORTC_QLQ15PAL. The alpha risk considered in this analysis is 0.05 / 9 = 0.0055 to avoid inflation of the latter following multiple comparisons (09 sub scores)
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End point type |
Secondary
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End point timeframe |
One week after locoregional analgesia installation
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| No statistical analyses for this end point | |||||||||
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End point title |
Emotional function score | ||||||||
End point description |
This score is calculated from the 02 items of EORTC_QLQ15PAL (Q13, Q14).The results of the comparison of the emotional function score between one week before the the implementation of locoregional anesthesia and one week after on a scale of 100.. The alpha risk considered in this analysis is 0.05 / 9 = 0.0055 to avoid inflation of the latter following multiple comparisons (09 sub scores).
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End point type |
Secondary
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End point timeframe |
One week after the implementation of locoregional anesthesia
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| No statistical analyses for this end point | |||||||||
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End point title |
Fatigue score | ||||||||
End point description |
This score is calculated from the 02 items of EORTC_QLQ15PAL (Q7, Q11). The results of the comparison of the fatigue score between one week before implementation of the locoregional anesthesia and one week after on a scale of 100 are shown below. The alpha risk considered in this analysis is 0.05 / 9 = 0.0055 to avoid inflation of the latter following multiple comparisons (09 sub scores).
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End point type |
Secondary
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End point timeframe |
One week after the implementation of the locoregional anesthesia
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| No statistical analyses for this end point | |||||||||
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End point title |
Dyspnea score | ||||||||
End point description |
This score is calculated from item (Q4) of EORTC_QLQ15PAL. The results of the comparison of the dyspnea score between one week before fitting the device and one week after on a scale of 100. The alpha risk considered in this analysis is 0.05 / 9 = 0.0055 to avoid inflation of the latter following multiple comparisons (09 sub scores).
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End point type |
Secondary
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End point timeframe |
One week after the implementation of the locoregional anesthesia
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| No statistical analyses for this end point | |||||||||
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End point title |
Insomnia score | ||||||||
End point description |
This score is calculated from item (Q6) of EORTC_QLQ15PAL. The results of the comparison of the insomnia score between one week before fitting the device and one week after on a scale of 100 a. The alpha risk considered in this analysis is 0.05 / 9 = 0.0055 to avoid inflation of the latter following multiple comparisons (09 sub scores)
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End point type |
Secondary
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End point timeframe |
One week after the implemtation of the locoregional anesthesia
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| No statistical analyses for this end point | |||||||||
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End point title |
Constipation score | ||||||||
End point description |
This score is calculated from item (Q8) of EORTC_QLQ15PAL. The results of the comparison of the constipation score between one week before fitting the device and one week after on a scale of 100 . The alpha risk considered in this analysis is 0.05 / 9 = 0.0055 to avoid inflation of the latter following multiple comparisons (09 sub scores).
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End point type |
Secondary
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End point timeframe |
One week after the installation of locoregional anesthesia
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| No statistical analyses for this end point | |||||||||
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End point title |
Evolution of the painful state between before the installation of the locoregional device and 48 hours after | ||||||||
End point description |
Comparison of the EORTC _PAL15 pain sub-score between one week before and 48 hours after placement of the device with an alpha risk = 0.0055 .
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End point type |
Secondary
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End point timeframe |
48 hours after the installation of the locoregional device
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| No statistical analyses for this end point | |||||||||
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End point title |
Quality of life using the ITEM 15 of the EORTC-15 PAL between one week before and 48 hours after the installation of the locoregional analgesia device | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
48 hours after the installation of the locoregional analgesia device
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| No statistical analyses for this end point | |||||||||
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End point title |
Improvement in quality of life using ITEM 15 of the EORTC-15 PAL | ||||||||
End point description |
Improvement in quality of life using ITEM 15 of the EORTC-15 PAL between 1 month after and one week before the implementation of the locoregional analgesia device
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End point type |
Secondary
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End point timeframe |
1 month after the implementaion of the locoregional analgesia device
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| No statistical analyses for this end point | |||||||||
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End point title |
Consumption of morphine treatments | ||||||||
End point description |
The comparison of the amount of morphine consumed (morphine equivalent) over a 24-hour period before the onset of locoregional analgesia and 1 week after was made using a wilcoxon test on paired series.
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End point type |
Secondary
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End point timeframe |
One week after the implementation of the locoregional analgesia device
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From inclusion up to 1 month after the patient's discharge.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Ovral trial
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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? 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 | |||
