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Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

NCT ID: NCT01689597

Last Updated: 2017-09-26

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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This pilot study intends to establish the efficacy of 2 different doses of epidural morphine for pain management after perineal trauma when using multimodal analgesia as well as the feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid consumption for breakthrough pain in the first 24 hours.

Detailed Description

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Conditions

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Traumatic Vaginal Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose epidural morphine

One dose of 1.25 mg epidural morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Comparison of different dosages of drug

High dose epidural morphine

One dose of 2.5 mg epidural morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Comparison of different dosages of drug

Saline

One dose of 10 ml saline administered through an epidural catheter

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Morphine

Comparison of different dosages of drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient is 18 years or older
* The patient is ASA 1-3
* Gestation 37-42 weeks
* The patient had a vaginal delivery
* The patient received epidural analgesia for labor and delivery

Exclusion Criteria

* The patient has refused to participate
* The patient cannot give informed consent
* The investigator has significant concerns for maternal or neonatal welfare
* The patient has a history of allergy to opioids
* The patient has a history of chronic opioid consumption
* The patient has a history of narcotic abuse
* The patient has an allergy to local anesthetics
* The patient has a contraindication to taking NSAIDs or acetaminophen
* The patient received combined spinal-epidural analgesia
* The patient has a history of chronic pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sudha I Singh, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

The University of Western Ontario

Other Identifiers

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18501

Identifier Type: -

Identifier Source: org_study_id