Epidural Morphine Following Vaginal Delivery

Mount Sinai Hospital, Canada

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Preservative-free epidural morphine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00803114

MSHREB 01-0227-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups, including a placebo group

Epidural Morphine

Experimental group

Description:

2.5 mg dose of epidural morphine given within one hour following vaginal delivery

Treatment:

Drug: Preservative-free epidural morphine

Placebo

Placebo Comparator group

Description:

5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Treatment:

Drug: Placebo