We would like to research wether there is a difference in time of mobilization between women getting iv PCA with Morphine (PCA)as opposed to women getting continuous epidural analgesia (CEA)with bupivacaine and sufentanil.We expect that the PCA will…
ID
Source
Brief title
Condition
- Postpartum and puerperal disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mobilization, how many hours after cesarean section does the patient stand
beside the bed?
VAS pain score post partum.
Secondary outcome
Time between caesarean section and stop PCA or CEA in hours.
Time between caesarean section and discharge in hours.
Use of oral pain relief.
Side effects: nausea and vomitting, sedation score, pruritis.
Background summary
The last decennia the number of caesarean sections has risen considerably.
In the Eighties around 10% of the deliveries ended in a caesarean section.
Nowadays an averge of 15-20% caesarean sections is the norm. In Holland we have
a rapid turnover, as women with a normal uncomplicated vaginal delivery are
discharged within hours after child birth. After a caesarean section women are
allowed to stay 72 hours in the hospital
Good pain relief is important after a caesarean section to give the mother a
chance to bond with her child. By being able to mobilize, she can take care of
her baby herself. By achieving an early discharge, she can go home and take
over control completely. She will also have a home help the first week. Good
painrelief also shouldn*t make mothers sleepy or drowsy, so they could miss
valuable first impressions. Last but not least the hospital would benifit from
an earlier discharge, because of the high turnover in the labour wards. In the
Netherlands having 180.000 deliveries per annum, it would with the current
section rate cocern 36.000 post natal cares.
Discharge shouldn*t be hindered by controlable factors as pain.
Study objective
We would like to research wether there is a difference in time of mobilization
between women getting iv PCA with Morphine (PCA)as opposed to women getting
continuous epidural analgesia (CEA)with bupivacaine and sufentanil.
We expect that the PCA will be as effective as CEA, but that women will
mobilize earlier and therefor be able to look after their child sooner. We will
perform the research within our own hospital.
Study design
The proposed study is a randomized study on location with control group. The
Kennemer Gasthuis has a minimum of 1500 high risk deliveries per annum. The
caesarean section percentage is around 20 %. The amount of elective caesarean
sections was 173 in 2012.
The research population will be asked to participate in the research at 34
weeks pregnancy at theclinic.
Group A will get PCA iv with morphine 2mg/ml, bolus 2 mg, lock out period 5
minutes, maximum 30 mg in 4 hours. Group B will get continuous epidural
analgesia (CEA) with bupivacaine 0,125% (50 ml) combined with sufentanil 50
micrograms= 1 ml, infusion rate 4-10 ml/hr., starting with 6 ml/hr or higher.
Intervention
Group A will get iv PCA with morphine 2mg/ml, bolus 2 mg, lock out period 5
minutes, with a maximum of 30 mg in 4 hours.
Group B will get continuous epidural analgesia (CEA) with bupivacaine 0,125%
(50 ml) combined with sufentanil 50 micrograms= 1 ml, infusion rate 4-10 ml/hr,
starting with 6 ml/hr or higher.
Study burden and risks
Minimal, restricted to only a few questions at randomisation and during
admission in hospital.
Both methods of pain relief are standard for post-operative pain relief in our
hospital and in the Netherlands.
Boerhaavelaan 22
Haarlem 2035RC
NL
Boerhaavelaan 22
Haarlem 2035RC
NL
Listed location countries
Age
Inclusion criteria
ASA1 and ASA2 pregnant women scheduled for primary caesarean section
Exclusion criteria
no informed consent
pre-eclampsia
coagulation disorders
ASA 3 and more
allergy for morphine, sufentanil or bupivacaine
local infection on the site of injection of the epidural.
increased intracranial pressure.
uncorrected hypovolemia.
relative contra-indications for epidural such as:
neurological disorders like multiple sclerosis,
malformation of the back,
history of back operations,
systemic infections.
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 | EUCTR2013-00-5168-2-NL |
CCMO | NL45365.094.13 |