Pain Clinical Trial
Official title:
Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour
Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.
Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and
stress associated with labour result in the activation of the sympathetic nervous system,
which increases plasma catecholamine concentrations with a resultant increase in cardiac
output, peripheral vascular resistance and eventually, reduction in utero-placental
perfusion. One aspect that has not been addressed in the literature is the role of
preventive analgesia in labour. We believe that the use of preventive epidural analgesia
will improve the quality of labour pain, increase maternal satisfaction and reduce the
stress response in labour.
The multiparous parturients that are scheduled for elective inductions of labour will be
offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in
a double blind fashion, one of two possible epidural drug regimens, which are a saline
placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient
then undergoes routine induction and management of labour. At any point after induction of
labour, patients in either group can request analgesia. Upon request for analgesia the
standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will
be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of
labor, from first request of epidural analgesia to full dilatation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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