Clinical trial NCT01689597: Epidural Morphine for Analgesia After Traumatic Vaginal Delivery
Official title: Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Traumatic Vaginal Delivery
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Total breakthrough opioid consumption
timeFrame: First 24 hours after delivery
Secondary outcomes:
measure: Pain scores at rest
timeFrame: At 6, 12, 24, and 36 h after delivery
measure: Pain scores with movement
timeFrame: At 6, 12, 24, and 36 h after delivery
measure: Severity of nausea/vomiting
timeFrame: At 6, 12, 24, and 36 h after delivery
measure: Severity of pruritis
timeFrame: At 6, 12, 24, and 36 h after delivery
measure: Severity of sedation
timeFrame: At 6, 12, 24, and 36 h after delivery
measure: Time to first request for additional analgesia
timeFrame: First 36 h after delivery
measure: Patient satisfaction with pain control
timeFrame: At 24 and 36 h after delivery
measure: Quality of Recovery
timeFrame: At 24 and 36 h after delivery
measure: Antiemetic consumption
timeFrame: First 36 h after delivery
measure: Antipruritic medication consumption
timeFrame: First 36 h after delivery
measure: Total opioid consumption
timeFrame: First 36 h after delivery
Other outcomes:
Locations:
Study officials:
affiliation: The University of Western Ontario
name: Sudha I Singh, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: