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Epidural Morphine Following Vaginal Delivery

This study has been completed.
The Physicians' Services Incorporated Foundation
Information provided by:
Mount Sinai Hospital, Canada Identifier:
First received: November 7, 2008
Last updated: January 13, 2009
Last verified: December 2008
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 Intervention Phase
Pain Drug: Preservative-free epidural morphine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Mount Sinai Hospital, Canada:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 228
Study Start Date: March 2002
Study Completion Date: February 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00803114

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

Responsible Party: Dr. Alison Macarthur, University of Toronto Identifier: NCT00803114     History of Changes
Other Study ID Numbers: MSHREB 01-0227-A
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: January 13, 2009

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

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 21, 2017