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Completed

NCT Number: NCT00803114

Epidural Morphine Following Vaginal Delivery

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preservative-free epidural morphine

Drug

One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery

Other names: Morphine, Epidural Narcotics

Placebo

Drug

5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Primary outcomes

  1. The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum

    Time frame: 24 hours postpartum

Secondary outcomes

  1. Time to First Request for Analgesia

    Time frame: Hours

    All participants requested analgesia at least once during their hospitalization

  2. Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic

    Time frame: by 24 hours postpartum

    Participants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with "no pain in my bottom" to the other end anchored with "the worst pain in my bottom that I can imagine"

  3. Maternal Satisfaction With Perineal Pain Management

    Time frame: at 24 hours postpartum

    5 point Likert scale asking for agreement with the statement "I was satisfied with my pain relief for the pain in my bottom during the first day after delivery". Scale ranged from strongly disagree to strongly agree.

  4. Side Effects

    Time frame: at 24 hours postpartum

    Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Dec 5, 2008
Registry last updated
Jan 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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