Application of intravenous lidocaïne and/or during surgery leads to a reduction of inflammation after breast cancer surgery

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002222-70-NL

Enrollment

Registered

2013-08-01

Start date

2013-11-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients who undergo surgery for treatment.

Interventions

Product Name: Lidocaine Product Code: RVG 51673 Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of admi

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is the impact of administering intravenous lidocaïne and dexamethasone on cytokine levels. ; 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. ; 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 ;Timepoint(s) of evaluation of this end point: 4 hours postoperatively	—

Measure

Time frame

Main Objective: The main objective of the trial is the impact of administering intravenous lidocaïne and dexamethasone on cytokine levels. ; 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. ; 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 ;Timepoint(s) of evaluation of this end point: 4 hours postoperatively

—

Secondary

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: 4 hours postoperatively	—

Countries

Netherlands

Contacts

Public ContactHead of Department Anesthesiology

UMCN St Radboud

K.Vissers@anes.umcn.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026