Clinical trial NCT00803114: Epidural Morphine Following Vaginal Delivery
Official title: Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Postpartum perineal pain
Epidural morphine
Randomised clinical trial
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2008-12-05
Enrollment: 228
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
timeFrame: 24 hours postpartum
Secondary outcomes:
measure: Time to First Request for Analgesia
timeFrame: Hours
measure: Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic
timeFrame: by 24 hours postpartum
measure: Maternal Satisfaction With Perineal Pain Management
timeFrame: at 24 hours postpartum
measure: Side Effects
timeFrame: at 24 hours postpartum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Alison J Macarthur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.rapm.2004.11.010.
citation: Macdonald R, Smith PJ. Extradural morphine and pain relief following episiotomy. Br J Anaesth. 1984 Nov;56(11):1201-5. doi: 10.1093/bja/56.11.1201.
citation: 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. doi: 10.1097/00002508-199412000-00013.