To compare Remifentanil PCA with epidural anesthesia among healthy nulligravidia during labor.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients' satisfaction
Secondary outcome
Outcome of the infant, APGAR.
Vacuum or forceps deliveries
Background summary
In the Netherlands analgesia during labor consists of Pethidin im or epidural
analgesia. Both methods have their side effects. Pethidin has a half life of
3-4 hours and can be quite sedative and can cause impaired thinking with
hallucinations. Especially the respiratoiry depression may be a threat to the
infant. With the introduction of the Remifentanil PCA on our OBGY ward we, as
in the current literature, experience less opiod side effects as seen with
Pethidin. Remifentanil has a half life of only a few minutes. Therefore, we
hypothise that remifentanil is an attractive replacer of Pethidin, and in
addition, a competitive treatment of epidural analgesia. Introducing epidural
analgesia on the ward often causes a delay since an anesthesiologist is
required. Moreover, patients are restricted to bed, somethimes describe the
feeling of not being part of the labor process and increased risk for vacuum or
forceps delivery and unexplained fever.
Study objective
To compare Remifentanil PCA with epidural anesthesia among healthy
nulligravidia during labor.
Study design
Two groups of healthy nulligravida, the study group with Remifentanil PCA, and
the control group with epidural anesthesia are compared.
Intervention
The study group receives a Remifantanil PCA, which will be connected to the IV
line. The control group receives a standard epidural procedure for catheter
placement.
Study burden and risks
Both methods of analgesia are applied methods of analgesia during labor. There
are no expected increased risks associated.
Jan Tooropstraat 164
1061 AE Amsterdam
NL
Jan Tooropstraat 164
1061 AE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
nulligravida
without serious systemic disease
in partu, less than 6cm dilatation
healthy
in labour
Exclusion criteria
American Society of Anesthesiologists (ASA) >2
(pre)eclampsia
HELLP syndrome
serious diabetic gravidarum
infection
placenta praevia
psychiatric disorder
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2007-005424-33-NL |
CCMO | NL17308.029.07 |
Other | volgt |