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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Preservative-free epidural morphine Drug: Placebo Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
Study Start Date : March 2002
Actual Primary Completion Date : November 2004
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural Morphine
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
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

Placebo Comparator: Placebo
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
Drug: Placebo
5 ml of epidural preservative-free saline given within one hour following vaginal delivery




Primary Outcome Measures :
  1. The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum [ Time Frame: 24 hours postpartum ]

Secondary Outcome Measures :
  1. Time to First Request for Analgesia [ Time Frame: Hours ]
  2. Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic [ Time Frame: by 24 hours postpartum ]
  3. Maternal Satisfaction With Perineal Pain Management [ Time Frame: at 24 hours postpartum ]
  4. Side Effects [ Time Frame: at 24 hours postpartum ]


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803114


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Alison J Macarthur, MD University of Toronto

Publications:
Responsible Party: Dr. Alison Macarthur, University of Toronto
ClinicalTrials.gov Identifier: NCT00803114     History of Changes
Other Study ID Numbers: MSHREB 01-0227-A
First Posted: December 5, 2008    Key Record Dates
Results First Posted: December 5, 2008
Last Update Posted: January 14, 2009
Last Verified: December 2008

Keywords provided by Mount Sinai Hospital, Canada:
Postpartum perineal pain
Epidural morphine
Randomised clinical trial

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents