Epidural Morphine Following Vaginal Delivery
Information source: Mount Sinai Hospital, Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Preservative-free epidural morphine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mount Sinai Hospital, Canada Official(s) and/or principal investigator(s): Alison J Macarthur, MD, Principal Investigator, Affiliation: University of Toronto
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.
Clinical Details
Official title: Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
Secondary outcome: Time to First Request for AnalgesiaMaternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic Maternal Satisfaction With Perineal Pain Management Side Effects
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
Minimum age: 16 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada
Additional Information
Related publications: Goodman SR, Drachenberg AM, Johnson SA, Negron MA, Kim-Lo SH, Smiley RM. Decreased postpartum use of oral pain medication after a single dose of epidural morphine. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):134-9. Macdonald R, Smith PJ. Extradural morphine and pain relief following episiotomy. Br J Anaesth. 1984 Nov;56(11):1201-5. Niv D, Wolman I, Yashar T, Varrassi G, Rudick V, Geller E. Epidural morphine pretreatment for postepisiotomy pain. Clin J Pain. 1994 Dec;10(4):319-23.
Starting date: March 2002
Last updated: January 13, 2009
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