Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

Phase 4

Withdrawn

• Conditions: Traumatic Vaginal Delivery
• Interventions: Drug: Placebo; Drug: Morphine

• Registration Number: NCT01689597
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	One dose of 10 ml saline administered through an epidural catheter
Low dose epidural morphine	Morphine	One dose of 1.25 mg epidural morphine
High dose epidural morphine	Morphine	One dose of 2.5 mg epidural morphine

Primary Outcome Measures

Name	Time	Method
Total breakthrough opioid consumption	First 24 hours after delivery

Secondary Outcome Measures

Name	Time	Method
Severity of nausea/vomiting	At 6, 12, 24, and 36 h after delivery
Total opioid consumption	First 36 h after delivery
Pain scores at rest	At 6, 12, 24, and 36 h after delivery
Severity of pruritis	At 6, 12, 24, and 36 h after delivery
Antipruritic medication consumption	First 36 h after delivery
Pain scores with movement	At 6, 12, 24, and 36 h after delivery
Severity of sedation	At 6, 12, 24, and 36 h after delivery
Time to first request for additional analgesia	First 36 h after delivery
Patient satisfaction with pain control	At 24 and 36 h after delivery
Quality of Recovery	At 24 and 36 h after delivery
Antiemetic consumption	First 36 h after delivery