Women who have been operated for pregnancy with caesarean section
Conditions
Interventions
Trade Name: OxyContin
Product Name: OxyContin
Pharmaceutical Form:
Sponsors
Akershus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Known sensitivity against oxycodone. Women with pre conceptual other diseases (i.e ASA 3 or more)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Serum level of paracetamol at 0, 1, 2 and 6 hours Possible differences in analgesic effect as measured by NRS (Numeric Rating Scale) 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 | — |
Countries
Norway
Contacts
Public ContactAnaesthesia Dept
Akershus University Hospital
Outcome results
None listed