Remote ischemic preconditioning as a non-invasive, non-pharmacological method for pain relief during labour
ID
Bron
Verkorte titel
Aandoening
Remote ischemic preconditioning, RIPC
Labour pain
Baringspijn, bevallingspijn, RIPC, ischemische preconditionering
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The time between the intervention and the need for any (other) analgesia
Achtergrond van het onderzoek
Rationale: Remote ischemic preconditioning as a non-invasive, non-pharmacological method for pain relief during labour.
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
Study population: Women > 18 years at 37-42 gestational weeks and planned for labour induction.
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.
Main study parameters/endpoints: The time between the intervention and the need for any (other) analgesia
Doel van het onderzoek
Remote ischemic preconditioning as a non-invasive, non-pharmacological method for pain relief during labour
Onderzoeksopzet
This study requires to ask for pain and comfort scores after 10 minutes, 30 minutes, 1 hour and then every hour after the intervention till one hour after childbirth.
Onderzoeksproduct en/of interventie
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.
Publiek
Afdeling Anesthesiologie <br>
Postbus 9101 <br>
6500 HB Nijmegen
V.D. Linssen
Philips van Leydenlaan 25
6525 EX Nijmegen
Nijmegen
The Netherlands
(024) 36 55653
vera.linssen@radboudumc.nl
Wetenschappelijk
Afdeling Anesthesiologie <br>
Postbus 9101 <br>
6500 HB Nijmegen
V.D. Linssen
Philips van Leydenlaan 25
6525 EX Nijmegen
Nijmegen
The Netherlands
(024) 36 55653
vera.linssen@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Woman at 37-42 gestational weeks
- Aged > 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Analgesics < 6 hours before the study
- Raynaud phenomenon
- Systolic blood pressure > 200 mmHg
- 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
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL6554 |
NTR-old | NTR6768 |
CCMO | NL61233.091.17 |
OMON | NL-OMON45643 |