Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

NCT01689597 | Withdrawn Phase 4

• 1 other identifier: 18501
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

• Total breakthrough opioid consumption

  First 24 hours after delivery

Secondary Outcomes (11)

• 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

Study Arms (3)

Low dose epidural morphine

ACTIVE COMPARATOR

One dose of 1.25 mg epidural morphine

Drug: Morphine

High dose epidural morphine

ACTIVE COMPARATOR

One dose of 2.5 mg epidural morphine

Drug: Morphine

Saline

PLACEBO COMPARATOR

One dose of 10 ml saline administered through an epidural catheter

Drug: Placebo

Interventions

Morphine DRUG

Comparison of different dosages of drug

High dose epidural morphine; Low dose epidural morphine

Placebo DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sudha I Singh, MD FRCPC

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 26, 2017

Record last verified: 2012-09