High Dose Epidural Fentanyl for Second Stage Labor Analgesia

2016H0439

This study is being done to investigate if there is more effective pain relief during the latter stages of labor and delivery when epidural fentanyl 100mcg is administered compared to epidural fentanyl 20mcg.

2017-06-26

2025-12-01

2025-12-01

Recruiting

Early phase I

150

Inclusion Criteria: 1. Nulliparous women 2. Spontaneous labor 3. A single vertex presentation fetus at term (38-42 weeks) 4. Effective labor epidural analgesia with continuous epidural infusion established 5. Provide written consent to participate in the study. Exclusion Criteria: 1. Multigravida women 2. Multigestation pregnancies 3. Patients being treated/managed for chronic pain 4. Allergies or significant adverse reactions to local anesthetic or opioid medications 5. Inadequate or unsatisfactory labor epidural analgesia 6. Patients with history of spine abnormalities or spine surgery 7. Non-English speaking 8. Prisoners 9. Age less than 18 years old

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assigned to one of two groups: one group will receive lower dose epidural fentanyl (20 micrograms) combined with local anesthetic; and one group will receive higher-dose epidural fentanyl (100micrograms) combined with the same amount of local anesthetic.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The subject and the research personnel will be blinded to the arm to which they are randomized. Only the clinician assessing the patient and administering epidural doses will be not be blinded to the study group.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-01-25