Ropivacaine and Fentanyl for Labor Epidural Initiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine + Fentanyl.
- Who it may be relevant to
- Registry conditions: Pregnancy, Labor and Delivery, Labor Analgesia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Ropivacaine + Fentanyl
A standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used.
Primary outcome measures
- Numerical Pain score [Time frame: 30 mins post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Publications
- Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798. PMID 28067707
- Song Y, Song Y, Sheng Z, Zhao Q, Liu W, Li Y, Zang Y, Xu Z, Liu Z. Exploration of the optimal programmed intermittent epidural bolus volume with the dural puncture epidural technique for labour analgesia: a biased-coin up-and-down sequential allocation study. Can J Anaesth. 2025 Feb;72(2):254-261. doi: 10.1007/s12630-024-02855-6. Epub 2024 Oct 21. PMID 39433721
- Maeda A, Villela-Franyutti D, Lumbreras-Marquez MI, Murthy A, Fields KG, Justice S, Tsen LC. Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the Effective Dose for 90% of Patients of Bupivacaine. Anesth Analg. 2024 Jun 1;138(6):1205-1214. doi: 10.1213/ANE.0000000000006691. Epub 2023 O PMID 37824436
Identifiers
NCT: NCT07076368 · 25-43988