E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locoregional analgesia in breast surgery (either conservative or non-conservative breast surgery associated with axillary dissection). |
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E.1.1.1 | Medical condition in easily understood language |
Locoregional analgesia in breast surgery: anesthesia that eliminates pain only in the region of the surgery. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054799 |
E.1.2 | Term | Perioperative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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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E.2.2 | Secondary objectives of the trial |
1) To evaluate the incidence of chronic pain in both groups at 6 months postoperatively. 2) To evaluate the acute pain intensity until 48h postoperatively. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age ≥18 years old 2. Female 3. Subjects undergoing either a conservative or non-conservative breast surgery associated with axillary dissection 4. ASA score ≤ 3 5. Completion of all necessary screening procedures within 30 days prior to randomisation 6. 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 7. Adequate Liver Function, including all of the following parameters: a. Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome b. Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN c. Alkaline phosphatase ≤ 2.5 x ULN 8. Signed informed consent 9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures |
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E.4 | Principal exclusion criteria |
1. Any illness or medical condition that is unstable or could jeopardize the safety of the patient or her compliance with study requirements 2. Allergy to local anaesthetics 3. Known allergy or hypersensitivity to Paracetamol, Diclofenac, Piritramide or excipients 4. Coagulopathy or taking oral anticoagulant/antiaggregant within 7 days before surgery 5. BMI> 35 kg / m2 6. Infection near the puncture site 7. Inability to understand pain assessment scales (Visual Analog Scale and Mc Gill Pain questionnaire) 8. Severe hepatic impairment: elevated transaminases with factor V ≤ 50% 9. Severe heart failure: NYHA classification III or IV and/or LVEF < 50% 10. Pregnant or lactating women 11. Concurrent treatment with daily basis chronic opiate type painkillers not ended 1 month prior surgery 12. Scheduled breast reconstruction at the time of surgery 13. Metastatic subjects 14. Subjects with breast implants. 15.Patients that require bilateral mastectomy or bilateral lumpectomy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total Piritramide consumption.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Piritramide consumption in the first 24 h post-surgery will be recorded. |
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E.5.2 | Secondary end point(s) |
1) Chronic pain intensity 2) Acute pain intensity |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Chronic pain intensity at 6 months post-surgery assessed by Mc Gill Pain Questionnaire. 2) Acute pain intensity until 48 hours post-surgery assessed by Visual Analog scale. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study will be declared when all the following criteria will have been met: - After last visit of the last subject - The trial is mature for the analysis of all the endpoints as defined in the protocol, if the trial reaches its endpoints - The database has been fully cleaned and frozen for all analyses |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |