A Comparison of Epidural Techniques for Labour Analgesia

NCT ID: NCT03065569

Last Updated: 2018-05-24

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-07

Study Completion Date

2018-05-07

Brief Summary

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A trial comparing outcomes for different epidural techniques in labour analgesia

Detailed Description

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Epidurals are the most common form of pain relief in labour. There are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (CSE). CSE has been shown to work faster and provide better pain relief than epidural alone. The investigators aim to show that CSE also requires less medication over the course of labour as this may mean it has fewer side effects. The amount of medication needed during labour between the two different techniques given in a standardized way will be compared.

Conditions

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Labour Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard Epidural Technique

Epidural will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

16 mL of 0.125% bupivacaine

Combined Spinal Epidural Technique

CSE will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

16 mL of 0.125% bupivacaine

Interventions

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Bupivacaine

16 mL of 0.125% bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, singleton presentation at term

Exclusion Criteria

* Significant comorbidities likely to alter outcome of labour
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Anton Chau

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anton Chau, MD MMSc

Role: PRINCIPAL_INVESTIGATOR

UBC

Locations

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BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

British Columbia's Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H16-03380

Identifier Type: -

Identifier Source: org_study_id

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