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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 Analgesia

Maternal 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

Page last updated: August 23, 2015

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