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Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Lawson Health Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Indu Singh, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01689597
First received: September 18, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Traumatic Vaginal Delivery
Drug: Morphine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Total breakthrough opioid consumption [ Time Frame: First 24 hours after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores at rest [ Time Frame: At 6, 12, 24, and 36 h after delivery ] [ Designated as safety issue: No ]
  • Pain scores with movement [ Time Frame: At 6, 12, 24, and 36 h after delivery ] [ Designated as safety issue: No ]
  • Severity of nausea/vomiting [ Time Frame: At 6, 12, 24, and 36 h after delivery ] [ Designated as safety issue: No ]
  • Severity of pruritis [ Time Frame: At 6, 12, 24, and 36 h after delivery ] [ Designated as safety issue: No ]
  • Severity of sedation [ Time Frame: At 6, 12, 24, and 36 h after delivery ] [ Designated as safety issue: No ]
  • Time to first request for additional analgesia [ Time Frame: First 36 h after delivery ] [ Designated as safety issue: No ]
  • Patient satisfaction with pain control [ Time Frame: At 24 and 36 h after delivery ] [ Designated as safety issue: No ]
  • Quality of Recovery [ Time Frame: At 24 and 36 h after delivery ] [ Designated as safety issue: No ]
  • Antiemetic consumption [ Time Frame: First 36 h after delivery ] [ Designated as safety issue: No ]
  • Antipruritic medication consumption [ Time Frame: First 36 h after delivery ] [ Designated as safety issue: No ]
  • Total opioid consumption [ Time Frame: First 36 h after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689597

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Sudha I Singh, MD FRCPC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Indu Singh, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01689597     History of Changes
Other Study ID Numbers: 18501
Study First Received: September 18, 2012
Last Updated: September 20, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014