Determination of the 90% Effective Volume (ED90) of Epidural 0.1% Ropivacaine and Fentanyl for Labor Analgesia Initiation in Patients Receiving a Dural-Puncture Epidural Technique
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Numerical Pain score
Study Overview
Brief Summary
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.
Detailed Description
We aim to perform a prospective observational study in a single cohort of 50 patients receiving a dural-puncture epidural technique for labor analgesia. We will use a biased-coin up-down allocation methodology to quantify the volume of a combined epidural 0.1% ropivacaine and 2 mcg/ml fentanyl regimen that achieves effective analgesia in 90% of patients experiencing active labor who receive a dural-puncture epidural technique for labor analgesia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Significant obstetric disease (e.g., pre-eclampsia, major cardiac disease)
- •Chronic pain or chronic opioid use
- •Multiple gestations
- •Allergy or anaphylaxis to local anesthetic
- •Fetal compromise or non-reassuring fetal trace
- •Age under 18
- •Inability to speak and understand English or Spanish
Arms & Interventions
Observational Cohort
Patients with singleton vertex pregnancies in active labor (spontaneous or after induction of labor), with a cervical dilatation between 1 and 7cm who are requesting neuraxial labor analgesia, Age =>18 yrs
Intervention: Ropivacaine + Fentanyl (Drug)
Outcomes
Primary Outcomes
Numerical Pain score
Time Frame: 30 mins post-intervention
Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain).
Secondary Outcomes
No secondary outcomes reported