Traumatic Vaginal Delivery
Conditions
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.
Interventions
DRUGMorphine
Comparison of different dosages of drug
DRUGPlacebo
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total breakthrough opioid consumption | First 24 hours after delivery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Pain scores at rest | At 6, 12, 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 |
| Patient satisfaction with pain control | At 24 and 36 h after delivery |
Outcome results
None listed