Reduce the need for other analgesia after RIPC by investigating the efficacy of remote ischemic preconditioning on pain during labour.
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The time between the intervention and the need for any (other) analgesia.
Secondary outcome
• Women with 30% or more pain relief after 10 minutes, 30 minutes, one hour and
then every hour after treatment
• NRS scores and analgesic needs
• Rate of assisted vaginal birth
• Rate of caesarean section
• Apgar score
• Significant maternal morbidity; major postpartum haemorrhage, uterine
rupture, admission to an ICU, eclampsia or severe HELLP
• Adverse and serious adverse events
Background summary
Remote ischemic preconditioning as a non-invasive, non-pharmacological method
for pain relief during labour.
Study objective
Reduce the need for other analgesia after RIPC by investigating the efficacy of
remote ischemic preconditioning on pain during labour.
Study design
Randomized, single blinded, placebo controlled, pilot intervention study
Intervention
Randomization creates 2 groups. One group will undergo 3 cycles of ischemia for
5 minutes (50 mmHg above own systolic blood pressure) followed by 5 minutes of
reperfusion. In the other group the tourniquet pressure is 20 mmHg with the
same 3 cycles and this is the control group.
Study burden and risks
Participation involves 3 times 5 minutes or tourniquet pressure. There is no
risk associated with participation. Registration of NRS scores is routine
practice in accordance the VMS-criteria. Women are free to ask for regular
analgesics for pain management.
Philips van Leydenlaan 25
Nijmegen 6525 EX
NL
Philips van Leydenlaan 25
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
• Woman at 37-42 gestational weeks
• Aged > 18 years
Exclusion criteria
• Analgesics before study
• Raynaud phenomenon
• Post-traumatic lengthy hand reconstruction on both upper extremities
• Severe crushing injuries on both upper extremities
• Skin grafts on both upper extremities
• Patients with advice for epidural analgesia
• Patient with contraindications for epidural analgesia
• Obstetrical complications such as:
o Intrauterine fetal death
o Obstetric high care patient
o Bleeding disorders
o Thrombosis disorders
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL61233.091.17 |
| OMON | NL-OMON21798 |