Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

Lawson Health Research Institute

Status and phase: Withdrawn; Phase 4

Conditions: Traumatic Vaginal Delivery

Treatments: Drug: Morphine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01689597

18501

Details and patient eligibility

About

This pilot study intends to establish the efficacy of 2 different doses of epidural morphine for pain management after perineal trauma when using multimodal analgesia as well as the feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid consumption for breakthrough pain in the first 24 hours.

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is 18 years or older
• The patient is ASA 1-3
• Gestation 37-42 weeks
• The patient had a vaginal delivery
• The patient received epidural analgesia for labor and delivery

Exclusion criteria

• The patient has refused to participate
• The patient cannot give informed consent
• The investigator has significant concerns for maternal or neonatal welfare
• The patient has a history of allergy to opioids
• The patient has a history of chronic opioid consumption
• The patient has a history of narcotic abuse
• The patient has an allergy to local anesthetics
• The patient has a contraindication to taking NSAIDs or acetaminophen
• The patient received combined spinal-epidural analgesia
• The patient has a history of chronic pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Low dose epidural morphine

Active Comparator group

Description:

One dose of 1.25 mg epidural morphine

Treatment:

Drug: Morphine

High dose epidural morphine

Active Comparator group

Description:

One dose of 2.5 mg epidural morphine

Treatment:

Drug: Morphine

Saline

Placebo Comparator group

Description:

One dose of 10 ml saline administered through an epidural catheter

Treatment:

Drug: Placebo