Clinical Trial Results:
The DESIGN trial : A randomised, Double-blind, placEbo-controlled Study to assess the effectIveness of pectoral nerves block (Pecs) after breast surGery on Piritramide coNsumption.
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Summary
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EudraCT number |
2015-005574-38 |
Trial protocol |
BE |
Global end of trial date |
11 Jan 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Mar 2022
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First version publication date |
17 Mar 2022
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Other versions |
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Summary report(s) |
Summary |
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 |
IJB-SUR-DESIGN-2015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02655965 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Institut Jules Bordet
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Sponsor organisation address |
Rue Meylemeersch,90, Brussels, Belgium, 1070
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Public contact |
Kathleen Wiams , Institut Jules Bordet, +32 25413594, kathleen.wiams@bordet.be
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Scientific contact |
Kathleen Wiams, Institut Jules Bordet, +32 25413594, kathleen.wiams@bordet.be
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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 |
11 Jan 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jan 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jan 2022
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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 |
To evaluate the effectiveness of pecs block associated to a general anaesthesia in terms of total Piritramide consumption.
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Protection of trial subjects |
Throughout the study the dedicated sponsor study team members verified the data to ensure that:
- the rights and well-being of subjects were protected
- the reported trial data were accurate, complete and verifiable from source documents
- the conduct of the trial was compliant with the IHC-GCP, the applicable regulatory requirements, the study protocol and the study guidelines
Quality control activities combined central monitoring and clinical site monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2016
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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 |
Belgium: 57
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Worldwide total number of subjects |
57
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EEA total number of subjects |
57
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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) |
45
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
57 subjects were registered and randomised in the DESIGN trial: - 28 were randomised in the intervention arm: ropivacaine 3.5 mg/ml + clonidine 5 µg/ml - 29 were randomised in the control arm (NaCl 0.9%) | |||||||||||||||
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Pre-assignment
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Screening details |
Subjects will only be eligible for study participation if they meet all the following inclusion criteria. Subjects who exhibit any of the following conditions at screening will not be eligible for admission into the study. | |||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
57 | |||||||||||||||
Number of subjects completed |
57 | |||||||||||||||
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Period 1
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Period 1 title |
Treatment (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 |
Investigator, Subject | |||||||||||||||
Blinding implementation details |
Both treatments were be labelled by the pharmacist using a unique treatment identification code to ensure blinding of treatment. The active and placebo preparations were identical and presented in the same packaging to ensure blinding of the study medication.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A : Intervention arm | |||||||||||||||
Arm description |
10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Ropivacaine
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Investigational medicinal product code |
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Other name |
ropivacaine hydrochloride monohydrate
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
10 ml of 3.5 mg/ml injected between pectoral muscles
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Investigational medicinal product name |
Clonidine
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Investigational medicinal product code |
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Other name |
clonidine hydrochloride
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
20 ml of 5 µg/ml between the muscles pectoralis minor and serratus anterior.
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Arm title
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Arm B : Control arm | |||||||||||||||
Arm description |
10 ml of placebo (sodium chloride 0.9% (NaCl 0.9%)) injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
sodium chloride 0.9% (NaCl 0.9%)
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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 |
Injection
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Dosage and administration details |
1000 ml solution for injection contains 9 g of sodium chloride
All subjects randomised in the Placebo arm will be injected (perineural use) with a solution of 10 ml of NaCl 0.9% between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior
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Baseline characteristics reporting groups
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Reporting group title |
Arm A : Intervention arm
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Reporting group description |
10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B : Control arm
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Reporting group description |
10 ml of placebo (sodium chloride 0.9% (NaCl 0.9%)) injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Arm A : Intervention arm
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Reporting group description |
10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | ||
Reporting group title |
Arm B : Control arm
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Reporting group description |
10 ml of placebo (sodium chloride 0.9% (NaCl 0.9%)) injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | ||
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End point title |
Piritramide consumption at 24 hours post‐operatively [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 hours post‐operatively
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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: The distributions of Piritramide consumption will be compared using a non-parametric test for location |
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Attachments |
Boxplot Untitled (Filename: Histogram.PNG) |
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End point title |
Chronic pain intensity at 6 months post-surgery | ||||||||||||
End point description |
Score obtained on the Mc Gill Pain questionnaire (SF-MPQ 2). The short form of the McGill Pain Questionnaire (SF-MPQ 2) consists of 22 descriptors (6 items related to continuous pain, 6 items related to intermittent pain, 8 items related to neuropathic pain and 4 items related to affective) which are rated on an intensity scale as 0 “no pain” to 10 “worst pain”.
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End point type |
Secondary
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End point timeframe |
all eligible patients, treated and without heavy surgery during the 6 months follow-up, having adequately filled the Mc Gill questionnaire will be analysed for this endpoint. Distributions of the overall score will be compared using a non-parametric
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Present pain intensity until 48 hours post-surgery at rest | ||||||||||||
End point description |
Present pain intensity post-surgery will be measured using VAS score (1–10).
The pain VAS is a single-item scale. For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10)
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End point type |
Secondary
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End point timeframe |
at rest : T0, 30 min, 1hr, 1h30, 2hrs, 4 hrs, 6 hrs, 8 hrs, 24 hrs, 32hrs, 48 hrs post surgery
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Present pain intensity until 48 hours post-surgery during movement | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
during movement : 2hrs, 4 hrs, 6 hrs, 8 hrs, 24 hrs, 32hrs, 48 hrs post surgery
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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 informed consent (IC) signature until 3 days after the last administration of study treatment, all AEs should be reported on the AE page of the CRF.
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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 |
24
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Reporting groups
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Reporting group title |
Arm A : Intervention arm
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Reporting group description |
10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B : Control arm
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Reporting group description |
10 ml of placebo (sodium chloride 0.9% (NaCl 0.9%)) injected between pectoral muscles and 20 ml of the same solution between the muscles pectoralis minor and serratus anterior | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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26 Sep 2016 |
- VAS assessments changes
- Adding one exclusion criteria: subjects that require bilateral mastectomy or bilateral lumpectomy |
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23 Oct 2017 |
- Inclusion and exclusion criteria clarification (Adequate liver function and cardiac function assessment)
- Length of study (recruitment period) |
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14 Nov 2018 |
ICF amendment due to changes in European Data Privacy legislative framework |
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03 Dec 2018 |
Sample size modification |
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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. | |||
| Due to slow accrual, the sample size has been modified (protocol version 4.0): targeting a statistical power of 0.80 instead of 0.90 | |||
