Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial

Conditions
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Postpartum Pain, Postpartum Depression, Opioid Consumption

Intervention / Treatment
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* Drug: Preservative Free Morphine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women in labor Exclusion Criteria: Not a candidate for neuraxial anesthesia Patient refusal Allergy to morphine Patients with chronic pain syndromes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, prospective, randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br>2mg preservative free morphine | Drug: Preservative Free Morphine<br>* After delivery of the baby patients will receive via the epidural catheter prior to its removal.<br>|
| Placebo Comparator: Saline<br>4 mL preservative free saline | Drug: Saline<br>* After delivery of the baby patients will receive via the epidural catheter prior to its removal.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Quantity of opioid used in 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain Score: Likert full scale 1-10, with higher score indicating more pain | up to 24 hours | 
| Obstetric Quality of Recovery Score (OBSQ10) | OBSQ10 total score 0-100, with higher score indicating better health status | 24 hours | 
| Edinburgh Postnatal Depression Scale (EPDS) | The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item instrument to assess postpartum depression, with total score from 0-30. Higher score indicates more depressed symptoms. | up to 6 weeks | 
| Number of participants with breast feeding success | Participants will respond yes/no as to their breast feeding success and continuation | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum depression, Postpartum anxiety, Postpartum opioids