Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Vaginal Delivery
• Intervention / Treatment: Drug: Placebo; Drug: Morphine

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low dose epidural morphine; One dose of 1.25 mg epidural morphine	Drug: Morphine; Comparison of different dosages of drug
Active Comparator: High dose epidural morphine; One dose of 2.5 mg epidural morphine	Drug: Morphine; Comparison of different dosages of drug
Placebo Comparator: Saline; One dose of 10 ml saline administered through an epidural catheter	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total breakthrough opioid consumption	First 24 hours after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain scores at rest	At 6, 12, 24, and 36 h after delivery
Pain scores with movement	At 6, 12, 24, and 36 h after delivery
Severity of nausea/vomiting	At 6, 12, 24, and 36 h after delivery
Severity of pruritis	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
Antipruritic medication consumption	First 36 h after delivery
Total opioid consumption	First 36 h after delivery

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Sudha I Singh, MD FRCPC, The University of Western Ontario

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: September 18, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 18501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No