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Preventive Analgesia in Multiparas Undergoing Induction of Labour

Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465231
Enrollment
16
Registered
2007-04-24
Start date
2007-01-31
Completion date
2007-06-30
Last updated
2007-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Induction of labour, Bupivacaine consumption, Prevention

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.

Interventions

10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml

10mL saline solution

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pain scores (VAS) remain 3 or lessthroughout the first stage of labor

Secondary

MeasureTime frame
Bupivacaine consumptionduring labour
Urinary creatinine to cortisol ratioduring labour
Neonatal outcomeat delivery
Obstetric outcomeat delivery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026