Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Cohort | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine + Fentanyl | Drug | A standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain score | Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain). | 30 mins post-intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant birthing patients
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Butwick, MBBS, FRCA, MS | Contact | 415-514-3757 | alexander.butwick@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Butwick, MBBS, FRCA, MS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28067707 | Background | 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. | |
| 39433721 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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. |
| 37824436 | Background | 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 Oct 12. |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |