Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Opioid Consumption; Postpartum Depression; Postpartum Pain

Treatments: Drug: Saline; Drug: Preservative Free Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT04017442

GCO 18-2789

Details and patient eligibility

About

Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.

Full description

After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women in labor

Exclusion criteria

• Not a candidate for neuraxial anesthesia
• Patient refusal
• Allergy to morphine
• Patients with chronic pain syndromes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Morphine

Experimental group

Description:

2mg preservative free morphine

Treatment:

Drug: Preservative Free Morphine

Saline

Placebo Comparator group

Description:

4 mL preservative free saline

Treatment:

Drug: Saline