Detection of the amount of local anesthesia absorbed by the blood after a regional breast analgesia technique for breast cancer surgery.

Phase 1

Active, not recruiting

Conditions: The aim of this study is to quantify peak and mean venous serum concentrations of ropivacaine after ultrasound guided Pecs II block with 2.5mg/kg ropivacaine diluted to 30ml.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2019-004813-15-BE

Lead Sponsor: AZ Turnhout

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria: (1) Age 18 or older (2) BMI between 17 and 35kg/m2, (3) scheduled for elective unilateral mastectomy or tumorectomy with sentinel node resection or axillary clearance, and (4) written informed consent.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients with (1)known allergies or sensitivity to local anaesthesia, or with (2) a BMI less than 17 or more than 35 kg/m2, (3) who are pregnant, (4) who have renal (GFR < 60ml/min) and/or hepatic impairment (end-stage liver disease that compromises normal hepatic drug metabolism) will be excluded. Given our inclusion and exclusion criteria, minors and subjects not capable of giving informed consent will be excluded from participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to quantify peak and mean venous serum concentrations of ropivacaine after ultrasound guided Pecs II block with 2.5mg/kg ropivacaine diluted to 30ml. ;Secondary Objective: Not applicable ;Primary end point(s): The aim of this study is to quantify peak and mean venous serum concentrations of ropivacaine after a Pecs II block with 2.5mg/kg ropivacaine diluted to 30ml. ;Timepoint(s) of evaluation of this end point: Ten blood samples will be obtained. Two blood samples will be obtained immediately after placement of the Pecs II block as one of these sample will be used to determine albumin and alpha-1-glycoprotein levels. The eight other blood sample will be obtained at 10, 20, 30, 45, 60, 90 and 120 minutes and at 4 hours after performing the Pecs II block.

Secondary Outcome Measures