Epidural Morphine Following Vaginal Delivery

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Preservative-free epidural morphine; Drug: Placebo

• Registration Number: NCT00803114
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2004-11
• Study Completion: 2005-02
• Study First Submitted: 2008-11-07
• Results First Submitted: 2008-11-07
• Status Verified: 2008-12
• Study First Submitted QC: 2008-12-04
• Results First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Results First Posted: 2008-12-05
• Last Update Submitted: 2009-01-13
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Morphine	Preservative-free epidural morphine	2.5 mg dose of epidural morphine given within one hour following vaginal delivery
Placebo	Placebo	5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Primary Outcome Measures

Name	Time	Method
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum	24 hours postpartum

Secondary Outcome Measures

Name	Time	Method
Time to First Request for Analgesia	Hours	All participants requested analgesia at least once during their hospitalization
Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic	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"
Maternal Satisfaction With Perineal Pain Management	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.
Side Effects	at 24 hours postpartum	Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada