Determination of the Optimal Ropivacaine Dose for Labor Analgesia Initiation Via Double Dural Puncture Epidural Technique: A Sequential Allocation Study
| Registry | NCT07882004 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | General Hospital of Ningxia Medical University (Other) |
| Conditions | Labor Pain |
| Interventions | 0.1% Ropivacaine (Drug) |
| Dates | start 2026-11-01 (estimated), primary completion 2027-03-30 (estimated), completion 2027-03-30 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
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All trials for Labor Pain All trials of 0.1% Ropivacaine
This study aims to determine the 90% effective dose (ED₉₀) of an initial regimen of 0.1% ropivacaine combined with 0.3 μg/mL sufentanil, administered via the double dural puncture epidural technique for epidural labor analgesia.
Epidural labor analgesia is a widely adopted pain management modality for parturition. Recent technical advances including the dural puncture epidural (DPE) technique have considerably improved the quality of the childbirth experience. The double dural puncture epidural technique appears to improve this effect more effectively. This study aims to determine the 90% effective dose (ED₉₀) of an initial regimen of 0.1% ropivacaine + 0.3 μg/mL sufentanil, administered via the double dural puncture epidural technique for epidural labor analgesia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Double dural puncture epidural group | Experimental | Drug: 0.1% Ropivacaine | Labor analgesia via double dural puncture epidural technique |
Sex: Female, ages: 18 Years to 40 Years
Inclusion Criteria: * Singleton full-term pregnant women aged 18 years or above, scheduled to receive epidural labor analgesia; * Cervical dilation > 2 cm; * Numerical Rating Scale (NRS) pain score > 5; * American Society of Anesthesiologists Physical Status Classification II. Exclusion Criteria: * Contraindications to neuraxial analgesia (e.g., coagulation disorders, infection, increased intracranial pressure); * Severe pregnancy complications, including hypertensive disorders of pregnancy and diabetes mellitus; * Fetal distress; * Allergies to local anesthetics or opioids; * Receive analgesic pharmacotherapy