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Clinical Trials/EUCTR2012-002222-70-NL
EUCTR2012-002222-70-NL
Active, not recruiting
Phase 1

Pilot study: Targeting the inflammatory response after breast cancer surgery with lidocaïne and dexamethasone

niversity Medical Centre St Radboud0 sites48 target enrollmentAugust 1, 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Breast cancer patients who undergo surgery for treatment.
Sponsor
niversity Medical Centre St Radboud
Enrollment
48
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity Medical Centre St Radboud

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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