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Preventive Analgesia in Multiparas Undergoing Induction of Labour

Not Applicable
Completed
Conditions
Pain
Interventions
Drug: preservative free saline
Registration Number
NCT00465231
Lead Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
16
Inclusion Criteria
  • Multiparous patients who had previous vaginal delivery, undergoing induction of labour
  • Singleton Pregnancy
Exclusion Criteria
  • Morbid Obesity
  • Patients who have received cortisol, opioids or sedatives within the last 24 hours

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1bupivacaine, fentanylEpidural
2preservative free salineEpidural - saline solution
Primary Outcome Measures
NameTimeMethod
Pain scores (VAS) remain 3 or lessthroughout the first stage of labor
Secondary Outcome Measures
NameTimeMethod
Obstetric outcomeat delivery
Bupivacaine consumptionduring labour
Urinary creatinine to cortisol ratioduring labour
Neonatal outcomeat delivery

Trial Locations

Locations (1)

Mount Sinai Hospital

🇨🇦

Toronto, Ontario, Canada

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