Labor Analgesia, Labor and Delivery, Pregnancy
Conditions
Keywords
epidural, labor analgesia, pregnancy, obstetric anesthesia
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.
Interventions
A standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-center, double-blind, prospective study that will use a biased-coin-up-down allocation study design to quantify the effective volume in 90% of laboring patients (EDV) after a dural-puncture epidural (DPE) technique for neuraxial analgesia. We wish to declare that the participant, care providers, and outcomes assessor will be masked. The ClinicalTrials website does not allow us to tick these roles for a single-arm study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * BMI ≥ 50 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain score | 30 mins post-intervention | Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain). |
Countries
United States
Contacts
CONTACTAlexander Butwick, MBBS, FRCA, MS
PRINCIPAL_INVESTIGATORAlexander Butwick, MBBS, FRCA, MS
University of California, San Francisco
Outcome results
None listed