NCT00465231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

April 23, 2007

Last Update Submit

December 12, 2007

Conditions

Pain

Keywords

Induction of labourBupivacaine consumptionPrevention

Outcome Measures

Primary Outcomes (1)

  • Pain scores (VAS) remain 3 or less

    throughout the first stage of labor

Secondary Outcomes (4)

  • Bupivacaine consumption

    during labour

  • Urinary creatinine to cortisol ratio

    during labour

  • Neonatal outcome

    at delivery

  • Obstetric outcome

    at delivery

Study Arms (2)

1

ACTIVE COMPARATOR

Epidural

Drug: bupivacaine, fentanyl

2

PLACEBO COMPARATOR

Epidural - saline solution

Drug: preservative free saline

Interventions

bupivacaine, fentanylDRUG

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

1
preservative free salineDRUG

10mL saline solution

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multiparous patients who had previous vaginal delivery, undergoing induction of labour
  • Singleton Pregnancy

You may not qualify if:

  • Morbid Obesity
  • Patients who have received cortisol, opioids or sedatives within the last 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jose CA Carvalho, MD PhD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

January 1, 2007

Study Completion

June 1, 2007

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

CA(1)