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Epidural Morphine Following Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT00803114
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 5, 2008
Last Update Posted : January 14, 2009
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Mount Sinai Hospital, Canada

November 7, 2008
December 5, 2008
November 7, 2008
December 5, 2008
January 14, 2009
March 2002
November 2004   (Final data collection date for primary outcome measure)
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum [ Time Frame: 24 hours postpartum ]
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum. [ Time Frame: 24 hours postpartum ]
Complete list of historical versions of study NCT00803114 on ClinicalTrials.gov Archive Site
  • Time to First Request for Analgesia [ Time Frame: Hours ]
  • Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic [ Time Frame: by 24 hours postpartum ]
  • Maternal Satisfaction With Perineal Pain Management [ Time Frame: at 24 hours postpartum ]
  • Side Effects [ Time Frame: at 24 hours postpartum ]
  • Side Effects [ Time Frame: at 24 hours postpartum ]
  • Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic [ Time Frame: by 24 hours postpartum ]
  • Time to First Request for Analgesia [ Time Frame: Hours ]
  • Maternal Satisfaction With Perineal Pain Management [ Time Frame: at 24 hours postpartum ]
Not Provided
Not Provided
 
Epidural Morphine Following Vaginal Delivery
Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.
Vaginal deliveries comprise 80-85% of all deliveries. Although this is felt to be natural and safe, this route can be associated with significant perineal trauma and subsequent postpartum perineal pain. The degree of perineal trauma varies from the minimum of vaginal stretching and distension associated with labor, to episiotomy and significant perineal tears. In spite of the differences in the degree of injury following vaginal delivery, postpartum pain therapy is poorly organized and at best consists of simple analgesics and anti-inflammatory drugs. The purpose of this study is to determine if a single dose of epidural-administered morphine offers additional advantage to an organized program for the management of immediate postpartum perineal pain following vaginal delivery.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pain
  • Drug: Preservative-free epidural morphine
    One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery
    Other Names:
    • Morphine
    • Epidural Narcotics
  • Drug: Placebo
    5 ml of epidural preservative-free saline given within one hour following vaginal delivery
  • Experimental: Epidural Morphine
    2.5 mg dose of epidural morphine given within one hour following vaginal delivery
    Intervention: Drug: Preservative-free epidural morphine
  • Placebo Comparator: Placebo
    5 ml of epidural preservative-free saline given within one hour following vaginal delivery
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
Same as current
February 2005
November 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.

Exclusion Criteria:

  • Women whose labor is terminated by cesarean delivery
  • Parturients with known morphine allergy
  • Parturients with narcotic addiction past / present
Sexes Eligible for Study: Female
16 Years to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00803114
MSHREB 01-0227-A
No
Not Provided
Not Provided
Dr. Alison Macarthur, University of Toronto
Mount Sinai Hospital, Canada
The Physicians' Services Incorporated Foundation
Principal Investigator: Alison J Macarthur, MD University of Toronto
Mount Sinai Hospital, Canada
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP