E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer patients who undergo surgery for treatment. |
borstkanker patienten die chirurgie ondergaan als behandeling |
|
E.1.1.1 | Medical condition in easily understood language |
Breast cancer patients who undergo surgery for treatment |
borstkanker patienten die chirurgie ondergaan als behandeling |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
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 |
The main objective of the trial is the impact of administering intravenous lidocaïne and dexamethasone on cytokine levels.
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Het effect van lidocaine en dexamethasone op cytokines concentraties perioperatief. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to investigate the relation of the early cytokine response to early acute pain scores and complications after breast surgery after breast cancer surgery ( lumpectomy/mastectomy with or without axillary lymph node dissection.
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Secundaire uitkomstmaten is de relatie van de cytokine respons met acute pijn scores en complicaties na lumpectomie |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Women undergoing breast cancer surgery : Lumpectomy, mastectomy with and without axillary lymph node dissection
- Women >18 years of age |
- Vrouwen die borstkanker chirurgie ondergaan ( Lumpectomie, mastectomy met en zonder okselklierdissectie.
- Vrouwen ouder dan 18 jaar |
|
E.4 | Principal exclusion criteria |
-Allergy to amide type of local anesthetics
-Recent myocardial ischemia ( <6months)
-Second or third degree AV conduction block
-Renal or liver failure
-Chronic opioïd use
-History of chronic pain
-Corticosteroid use
-No written informed consent by patient
|
-Allergie voor amide lokaal anesthetica
-Recent myocardinfarct
-Tweede of derdegraads AV blok
-Nier of leverfalen
-Chronisch opiaat gebruik
-Historie van chronische pijn
-Corticosteroid gebruik
-Geen informed consent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Pre operative and 4 hours post operative blood samples tested for cytokine ( IL-1B, IL-6, IL-10 and IL1Ra) levels
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- preoperatief en 4 uur postoperatief bloedafname voor cytokine bepalingen |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 hours postoperatively |
4 uur postoperatief |
|
E.5.2 | Secondary end point(s) |
- NRS scores before surgery and at 0 and 4 hours after surgery.
- The aim is a reduction of 2 points of NRS
- 30Day complication rate according to Clavien Dindo Classification
|
- NRS score pre operatief en op 0 en 4 uur postoperatief
- Het doel is een afname van 2 punten van de NRS
- 30 dagen complicatie ratio volgens de clavien dindo classificatie |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 hours postoperatively |
4 uur postoperatief |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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
|
The end point of the trial is after the last patient has fully undergone the research procedure; 3 pilot studies with 16 patients (total of 48 patients) will be conducted, and in every pilot patients will receive lidocaïne or placebo: Pilot 1. no dexamethasone is added; Pilot 2: dexamethasone 4mg is added; Pilot 3 dexamethasone 8mg is added |
Het eindpunt van de studie is nadat de laatste patient de volledige studieprocedure heeft ondergaan. Drie pilot studies met 16 patienten (totaal 48 patienten) worden uitgevoerd, bij welke elke pilot studie lidocaïne of placebo wordt toegediend . Pilot 1 geen dexamethasone; pilot 2 dexamethasone 4mg; pilot 3 dexamethasone 8mg |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |