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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005574-38 | EudraCT Number | ||
| CE2483 | Other Identifier | Institut Jules Bordet |
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The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).
This is a double-blind study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of 10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm A) versus 10 ml of placebo (NaCl 0.9%) injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm B). The pecs block will inject just before the surgery.
Subjects will receive a nausea and vomiting prophylaxy depending on Apfel score After surgery, the two intervention groups will receive before waking a dose of Paracetamol (1 g) and Diclofenac (75 mg), if they present no contraindications and a dose of 0.05 mg/kg Piritramide .
In the recovery room the two groups will benefit from a Patient Controlled Intravenous Analgesia (PCIA) pump - Piritramide allowing them to control their analgesia, which will be stopped at 24 hours postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine + Clonidine | Experimental | A "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml will be injected to the patients prior surgery. 10 ml of the drug combination will be injected between pectoral muscles and 20 ml of the drug combination will be injected between the muscles pectoralis minor and serratus anterior. After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery. |
|
| Sodium Chloride | Placebo Comparator | A "pecs block" of Placebo (Sodium Chloride 0.9%) will be injected to the patients prior surgery. 10 ml of the Sodium chloride solution will be injected between pectoral muscles and 20 ml of the Sodium chloride solution will be injected between the muscles pectoralis minor and serratus anterior). After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ropivacaine 3.5 mg/ml |
| |
| Clonidine |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the effectiveness of pecs block in terms of total Piritramide consumption | Piritramide consumption in the first 24 h post-surgery will be recorded | 24 hrs post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of incidence of chronic pain in both groups at 6 months postoperatively | Pain intensity until 6 months post-surgery will be evaluated using the Short version of Mc Gill questionnaire (SF-MPQ2) | 6 months post-surgery |
| Evaluation of present pain post-operatively |
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Inclusion Criteria:
Age ≥18 years old
Female
Subjects undergoing either a conservative or non-conservative breast surgery associated with axillary dissection
ASA score ≤ 3
Completion of all necessary screening procedures within 30 days prior to randomisation
Adequate Renal Function including: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution
Adequate Liver Function, including all of the following parameters:
Signed informed consent
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Sosnowski, MD | Jules Bordet Institute | Study Chair |
| Kathleen Wiams, MD | Jules Bordet Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003000 | Clonidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Clonidine 5µg/ml |
|
| Sodium Chloride | Drug | Sodium Chloride 0.9 % |
|
Present pain intensity until 48 hrs post- surgery will be assessed by Visual Analog scoring |
| 48 hours post-surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000588 |
| Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |