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Clinical trial

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

ID
Name
GCO 18-2789
Description
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.
Trial arms
Trial start
2019-10-19
Estimated PCD
2023-08-31
Trial end
2023-08-31
Status
Completed
Phase
Early phase I
Treatment
Preservative Free Morphine
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Arms:
Morphine
Saline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Arms:
Saline
Other names:
Placebo
Size
140
Primary endpoint
Opioid Consumption
24 hours
Eligibility criteria
Inclusion Criteria: * Pregnant women in labor Exclusion Criteria: * Not a candidate for neuraxial anesthesia * Patient refusal * Allergy to morphine * Patients with chronic pain syndromes
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind, prospective, randomized', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The only individual that will know to which group the patient was assigned is the individual on the study team who is drawing up the medication. This individual will have no other role in the assessment or evaluation of the patient.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

1 product

1 drug

3 indications

Organization
Icahn School of Medicine at Mount Sinai
Product
Morphine
Indication
Postpartum Pain
Indication
Postpartum Depression
Indication
Opioid Consumption
Drug
Varlilumab