Vaginal labor/delivery
Conditions
Interventions
Trade Name: Marcain injeksjonsvæske 5 mg/ml
Product Name: Marcain injeksjonsvæske 5 mg/ml
Pharmaceutical Form: Solution for injection/infusion
Trade Name: Fentanyl-Hameln 50 mikrog/ml injeksjonsvæske
Sponsors
Akershus university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Pregnant women requesting epidural analgesia • ASA group 1 and 2 • 0 or 1 previous births • Must be at least 18 years of age. • Singleton pregnancy • Active labor 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Poor communication skills in norwegian or english • Adverse reactions to local anesthetics or synthetic opioids • Body height below 150 cm • Gestational age below 37 weeks, 0 days • Any contraindication to epidural catheter placement (e.g. patients with coagulopathy, infection in area etc) • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to investigate whether use of intermittent epidural bolus (IEB) + patient controlled epidural bolus (PCEA) results in lower epidural mixture use per time compared to continuous epidural infusion + PCEA in the setting of an adrenaline containing mixture.;Secondary Objective: Secondary objectives are to investigate whether IEB+PCEA results in 1) increased maternal satisfaction 2) increased use of IAD or CD 3) increased use of anesthesiologic intervention 4) increased side effects (nausea, pruritus, hypotension, motor block);Primary end point(s): Dose of epidural mixture used per hour (ml/h);Timepoint(s) of evaluation of this end point: This will be evaulated after treatment ends (at delivery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall maternal satisfaction with treatment (scale of 0-10) • Incidense of IAD • Incidense of CD • Incidense of and time to anesthesiologic intervention • Incidense and intensity of nausea (mild, moderat, severe) • Incidense and intensity of pruritus (mild, moderat, severe) • Incidense of hypotension (systolic blod pressure < 90 mmHg) • Incidence and intensity of motor block of lower extremities (modified Bromage score; 0-3) at 1 hour and at 10 cm cervix dilation.;Timepoint(s) of evaluation of this end point: This will be evaulated after treatment ends (at delivery) | — |
Countries
Norway
Contacts
Public ContactProfessor
Akershus university hospital
Outcome results
None listed