Application of intravenous lidocaïne and/or during surgery leads to a reduction of inflammation after breast cancer surgery
Phase 1
- Conditions
- Breast cancer patients who undergo surgery for treatment.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-002222-70-NL
- Lead Sponsor
- niversity Medical Centre St Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
-Women undergoing breast cancer surgery : Lumpectomy, mastectomy with and without axillary lymph node dissection
- Women >18 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The main objective of the trial is the impact of administering intravenous lidocaïne and dexamethasone on cytokine levels.<br> <br> ;<br> Secondary Objective: 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. <br> ;<br> 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 <br> ;Timepoint(s) of evaluation of this end point: 4 hours postoperatively
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - NRS scores before surgery and at 0 and 4 hours after surgery.<br> - The aim is a reduction of 2 points of NRS <br> - 30Day complication rate according to Clavien Dindo Classification<br> <br> ;Timepoint(s) of evaluation of this end point: 4 hours postoperatively