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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Total breakthrough opioid consumption
Time frame: First 24 hours after delivery
Pain scores at rest
Time frame: At 6, 12, 24, and 36 h after delivery
Pain scores with movement
Time frame: At 6, 12, 24, and 36 h after delivery
Severity of nausea/vomiting
Time frame: At 6, 12, 24, and 36 h after delivery
Severity of pruritis
Time frame: At 6, 12, 24, and 36 h after delivery
Severity of sedation
Time frame: At 6, 12, 24, and 36 h after delivery
Time to first request for additional analgesia
Time frame: First 36 h after delivery
Patient satisfaction with pain control
Time frame: At 24 and 36 h after delivery
Quality of Recovery
Time frame: At 24 and 36 h after delivery
Antiemetic consumption
Time frame: First 36 h after delivery
Antipruritic medication consumption
Time frame: First 36 h after delivery
Total opioid consumption
Time frame: First 36 h after delivery
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