Clinical Trial Results:
The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.
Summary
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EudraCT number |
2013-002764-12 |
Trial protocol |
FR |
Global end of trial date |
07 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
07 May 2021
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First version publication date |
07 May 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 |
I12019
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01670448 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University Hospital, Limoges
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Sponsor organisation address |
02 avenue martin Luther King, Limoges, France, 87042
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Public contact |
coordinator investigator, University Hospital, Limoges, +33 555056300, jeromemcros@yahoo.fr
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Scientific contact |
coordinator investigator, University Hospital, Limoges, +33 555056300, jeromemcros@yahoo.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 |
31 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
07 May 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 |
Estimate the analgesic efficiency of the pectoral block
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Protection of trial subjects |
Patients are informed and an information note is issued. A consent is signed.
Patients are followed up to 7 days after the pectoral block
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2013
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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 |
Canada: 49
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Country: Number of subjects enrolled |
France: 79
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Worldwide total number of subjects |
128
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EEA total number of subjects |
79
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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) |
96
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From 65 to 84 years |
32
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85 years and over |
0
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Recruitment
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Recruitment details |
The pre-inclusion visit is provided by the doctor. The pre-inclusion visit takes place at the time of the anesthesia consultation. the doctor informs the patient about the study and answers all her questions. The patient has a period of reflection until the day of the surgery. The day before of surgery (inclusion visit), consent is obtained. | |||||||||
Pre-assignment
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Screening details |
patients are screened during staff meetings | |||||||||
Period 1
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Period 1 title |
inclusion
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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 | |||||||||
Blinding implementation details |
The pharmacy will make sealed, masked lots, with patient numbers according to the randomization list. These lots will be sent to the care unit no later than the morning of inclusion.
A nurse not involved in patient care will prepare the product for the open study (physiological saline or bupivacaine), the product will then be sent to the doctor with patient labeling without the possibility of identifying the group.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Bupivacaine | |||||||||
Arm description |
PECBLOCK performed with bupivacaine | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
bupivacaine
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Investigational medicinal product code |
N01BB01
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
All patients will have ultrasound guided pectoral block. Under general anesthesia and under sterile conditions, after ultrasound identification of the interpectoral space (between the pectoralis major and pectoralis minor muscles), a 22G and 50 mm needle will be inserted for the administration of 0.4 mL / kg of bupivacaine 0, 25% adrenaline (1/200,000) without exceeding 40 mL or de 0,4 mL/kg de NaCl 0,9%.
Patients weighing more than 100 kg will receive 40 mL of 0.25% bupivacaine adrenaline or 0.9% NaCl.
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Arm title
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Placebo | |||||||||
Arm description |
PECBLOCK performed with NaCl 0.9% | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
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 |
Intramuscular use
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Dosage and administration details |
All patients will have ultrasound guided pectoral block. Under general anesthesia and under sterile conditions, after ultrasound identification of the interpectoral space, a 22G and 50 mm needle will be inserted for the administration of 0.4 mL / kg of 0.9% NaCl.
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Period 2
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Period 2 title |
recovery room
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer | |||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Bupivacaine | |||||||||
Arm description |
Active drug given through PECBLOCK in these patients. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
bupivacaine
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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 |
Intramuscular use
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Dosage and administration details |
bupivacaïne 0,25% adrénalinée
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Arm title
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Placebo | |||||||||
Arm description |
Placebo drug given through PECBLOCK in these patients | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
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 |
Intramuscular use
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Dosage and administration details |
NaCl 0.9%
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Period 3
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Period 3 title |
first 24 hours post surgery
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Bupivacaine | |||||||||
Arm description |
Active drug given through PECBLOCK in these patients. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
bupivacaine
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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 |
Intramuscular use
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Dosage and administration details |
Active drug given through PECBLOCK in these patients.
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Arm title
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Placebo | |||||||||
Arm description |
Placebo drug given through PECBLOCK in these patients | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
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 solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
NaCl 0.9%
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Baseline characteristics reporting groups [1]
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Reporting group title |
inclusion
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Justification: a patient has withdrawn her consent |
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Subject analysis sets
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Subject analysis set title |
analgesic efficacy of the pectoral block
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
pain was assessed by a verbal simple numerical scale (ENS) 30 minutes after admission to the recovery room or just before morphine titration
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Subject analysis set title |
Assessment and comparison of pain scores at rest and on postop
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Assessment and comparison of pain scores at rest and on postoperative mobilization
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Subject analysis set title |
Comparison of Sufentanil Consumption During Surgery
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Comparison of Sufentanil Consumption During Surgery
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Subject analysis set title |
Comparison of morphine dose to recovery room
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Comparison of morphine dose to recovery room
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End points reporting groups
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Reporting group title |
Bupivacaine
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Reporting group description |
PECBLOCK performed with bupivacaine | ||
Reporting group title |
Placebo
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Reporting group description |
PECBLOCK performed with NaCl 0.9% | ||
Reporting group title |
Bupivacaine
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Reporting group description |
Active drug given through PECBLOCK in these patients. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo drug given through PECBLOCK in these patients | ||
Reporting group title |
Bupivacaine
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Reporting group description |
Active drug given through PECBLOCK in these patients. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo drug given through PECBLOCK in these patients | ||
Subject analysis set title |
analgesic efficacy of the pectoral block
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
pain was assessed by a verbal simple numerical scale (ENS) 30 minutes after admission to the recovery room or just before morphine titration
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Subject analysis set title |
Assessment and comparison of pain scores at rest and on postop
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Assessment and comparison of pain scores at rest and on postoperative mobilization
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Subject analysis set title |
Comparison of Sufentanil Consumption During Surgery
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Comparison of Sufentanil Consumption During Surgery
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Subject analysis set title |
Comparison of morphine dose to recovery room
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Comparison of morphine dose to recovery room
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End point title |
Pain score at rest in the recovery room | ||||||||||||||||||||||||
End point description |
Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable
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End point type |
Primary
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End point timeframe |
30 min after entering the recovery room
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Statistical analysis title |
end point 1 | ||||||||||||||||||||||||
Comparison groups |
Bupivacaine v Placebo v Bupivacaine v Placebo v Bupivacaine v Placebo v Assessment and comparison of pain scores at rest and on postop
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Number of subjects included in analysis |
508
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Analysis specification |
Post-hoc
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Analysis type |
superiority | ||||||||||||||||||||||||
P-value |
< 0.0001 | ||||||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||||||
Point estimate |
3
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
1 | ||||||||||||||||||||||||
upper limit |
4 | ||||||||||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
0
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End point title |
Total morphine consumption in the recovery room | ||||||||||||||||||||||||||||||||
End point description |
When surgery is over and the patient is brought to the recovery room, the total morphine consumption in mg used in the recovery (for pain less than 4/10) is recorded
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End point type |
Secondary
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End point timeframe |
in the recovery room before discharge (after 1 h on average)
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Statistical analysis title |
end point 2 | ||||||||||||||||||||||||||||||||
Comparison groups |
Bupivacaine v Placebo v Bupivacaine v Placebo v Bupivacaine v Placebo v Comparison of morphine dose to recovery room
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Number of subjects included in analysis |
508
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Analysis specification |
Post-hoc
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Analysis type |
superiority | ||||||||||||||||||||||||||||||||
P-value |
< 0.0001 | ||||||||||||||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||||||||||||||||||
Point estimate |
3
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
1 | ||||||||||||||||||||||||||||||||
upper limit |
6 | ||||||||||||||||||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
0
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End point title |
Total sufentanil consumption during surgery | ||||||||||||||||||||||||||||||||
End point description |
When surgery is over, 1-2 h on average depending if it is a tumorectomy or a mastectomy, the total sufentanil consumption in micrograms during surgery is recorded.
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End point type |
Secondary
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End point timeframe |
at the end of surgery (1-2 h on average)
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Statistical analysis title |
end point 3 | ||||||||||||||||||||||||||||||||
Comparison groups |
Bupivacaine v Placebo v Bupivacaine v Placebo v Bupivacaine v Placebo v Comparison of Sufentanil Consumption During Surgery
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Number of subjects included in analysis |
508
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Analysis specification |
Post-hoc
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Analysis type |
superiority | ||||||||||||||||||||||||||||||||
P-value |
< 0.0001 | ||||||||||||||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||||||||||||||||||
Point estimate |
20
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
15 | ||||||||||||||||||||||||||||||||
upper limit |
23 | ||||||||||||||||||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
0
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Adverse events information
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Timeframe for reporting adverse events |
post intervention
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Assessment type |
Non-systematic | |||||||||||||||||||||
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 |
Pacebo
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Reporting group description |
- | |||||||||||||||||||||
Reporting group title |
bupivacaïne
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Reporting group description |
- | |||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | ||||||||||||||||||||||
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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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18 Dec 2013 |
Modification of the non-inclusion criteria:
- Patient already operated on the ipsilateral breast in order not to recruit a patient who has already undergone an operation on the same breast
- Bilateral surgery: addition of this non-inclusion criteria in order not to bias the scores on pain |
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29672368 |