serum level of the morphine-like substance oxycodone after caesarean sectio

Conditions: Women who have been operated for pregnancy with caesarean section
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-003116-37-NO

Lead Sponsor: Akershus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Healthy women (ASA class 2) between 18 and 45 years with a single fetus undergoing an elective caesarean section under regional anesthesia. They must be at term (between 37+0 and 41+6 weeks pregnant), pre conception BMI (body mass index) between 18.5 and 24.9, height between 155 cm and 180 cm. They must have read and signed the written information.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known sensitivity against oxycodone. Women with pre conceptual other diseases (i.e ASA 3 or more)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: At our hospital, oxycodone is given orally to all woman who have had a caesarean section under regional anesthesia. Oxycodone is given orally when arriving to the postoperative care unit, and then again after 12 hours. The aim of this study is identify the amount of the IMP (oxycodone) that is actively taken up by the gut in the immediate postoperative period( 0, 1, 2 and 6 hours) by measuring the level of oxycodone in serum at specific periods and comparing it with degree of pain. ;Secondary Objective: Possible differences in analgesic effect and degree of analgesia and its relation to the serum level of oxycodone.<br>The speed of gastric emptying by measuring the level of paracetamol in serum at the same time periods;Primary end point(s): Serum level of oxycondone and paracetamol as measured at points 0 (reference), 1, 2 and 6 hrs after administration of oxycodone and paracetamol.;Timepoint(s) of evaluation of this end point: 0, 1, 2 and 6 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Serum level of paracetamol at 0, 1, 2 and 6 hours<br>Possible differences in analgesic effect as measured by NRS (Numeric Rating Scale)<br>Possible side effects of oxycodone (nausea/vomiting, pruritus and/or sedation);Timepoint(s) of evaluation of this end point: 0, 1, 2, and 6 hours postoperatively