Epidural Morphine Following Vaginal Delivery

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00803114
First received: November 7, 2008
Last updated: January 13, 2009
Last verified: December 2008
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to First Request for Analgesia [ Time Frame: Hours ] [ Designated as safety issue: No ]
  • Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic [ Time Frame: by 24 hours postpartum ] [ Designated as safety issue: No ]
  • Maternal Satisfaction With Perineal Pain Management [ Time Frame: at 24 hours postpartum ] [ Designated as safety issue: No ]
  • Side Effects [ Time Frame: at 24 hours postpartum ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Dr. Alison Macarthur, University of Toronto
ClinicalTrials.gov 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
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 01, 2014