Acute postoperative pain after gynaecologic surgery.
Conditions
Interventions
Trade Name: OXANEST®
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous bolus use (Noncurrent)
Pharmaceutical form of the
Sponsors
Anaesthesia and Operative Services, Kuopio University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women aged 18–75 yr undergoing elective gynaecological surgery with planned postoperative epidural analgesia. Patients must provide written 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patient is unwilling to give consent, has allergy/hypersensitivity to oxycodone or other ingredients in the formulations, has reduced respiratory function, has defects in the vertebral column that are likely to hinder the placement of epidural and spinal catheters, is pregnant or nursing, has a tendency for bleeding or is currently on an anticoagulant therapy, or who has used oxycodone during the previous week, or MAO, CYP3A, or CYP2D6 inhibitors during the previous month, cancer surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the analgesic efficacy and safety of epidural oxycodone.;Secondary Objective: To assess the safety of epidural oxycodone.;Primary end point(s): The need for rescue analgesics (total dose of i.v. fentanyl, mg) during the first four hours after surgery. ;Timepoint(s) of evaluation of this end point: At four hours after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The time to first need for rescue analgesics, pain scores on 11-point numeric rating scale (NRS, 0=no pain, 10=most pain), adverse effects and the concentration of oxycodone in cerebrospinal fluid (CSF), one CSF sample per patient.;Timepoint(s) of evaluation of this end point: The pain scores and adverse effects are recorded every 30 minutes during the first four hours after surgery, in the first postoperative evening in the ward and at 24 hours after surgery. The CSF samples are taken at four hours after surgery at the post-anesthesia care unit (PACU) before transmission to surgical ward. | — |
Countries
Finland
Contacts
Public ContactAnaesthesia and Operative Services
Kuopio university hospital
Outcome results
None listed