Epidural Morphine Following Vaginal Delivery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Preservative-free epidural morphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Morphine<br>2.5 mg dose of epidural morphine given within one hour following vaginal delivery | Drug: Preservative-free epidural morphine<br>* One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery<br>* Other names: Epidural Narcotics;|
| Placebo Comparator: Placebo<br>5 ml of epidural preservative-free saline given within one hour following vaginal delivery | Drug: Placebo<br>* 5 ml of epidural preservative-free saline given within one hour following vaginal delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum |  | 24 hours postpartum | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum perineal pain, Epidural morphine, Randomised clinical trial