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Preventive Analgesia in Multiparas Undergoing Induction of Labour

NCT ID: NCT00465231

Last Updated: 2007-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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Induction of labour Bupivacaine consumption Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Epidural

Group Type ACTIVE_COMPARATOR

bupivacaine, fentanyl

Intervention Type DRUG

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

2

Epidural - saline solution

Group Type PLACEBO_COMPARATOR

preservative free saline

Intervention Type DRUG

10mL saline solution

Interventions

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bupivacaine, fentanyl

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

Intervention Type DRUG

preservative free saline

10mL saline solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mount Sinai Hospital

Principal Investigators

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Jose CA Carvalho, MD PhD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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06-0230-A

Identifier Type: -

Identifier Source: secondary_id

07-01

Identifier Type: -

Identifier Source: org_study_id