Ropivacaine and Fentanyl for Labor Epidural Initiation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco
About this trial
This study is being done to determine the most effective dose of medicine to use to initially provide effective pain relief within the first 30 minutes of receiving an epidural for pain labor during labor. The study team will also study any side effects related to the epidural medication and patients' satisfaction with the quality of pain relief after receiving the epidural.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with singleton vertex pregnancies in active labor (latent or spontaneous labor or after induction of labor)
Cervical dilatation between 2 and 7 cm
Requesting neuraxial labor analgesia
Age 18 or older
Disqualifiers
Significant obstetric disease (e.g., pre-eclampsia, major cardiac disease)
Chronic pain or chronic opioid use
BMI ≥ 50
Multiple gestations
Trial design
Design model
Single group
Treatments tested in this trial
Ropivacaine + Fentanyl
DrugA standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Observational CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Pain score
Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain).
Time frame
30 mins post-interventionSponsors and contacts
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Source ClinicalTrials.gov