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Comparison of the ED95 of Initial Bolus Doses of Epidural, Dural Puncture Epidural, and Double Dural Puncture Epidural for Labor Analgesia: A Randomized Sequential Trial.

Comparison of the ED95 of Initial Bolus Doses of Epidural, Dural Puncture Epidural, and Double Dural Puncture Epidural for Labor Analgesia: A Randomized Sequential Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119181
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-25
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

EP Group:Epidural Analgesia
DPE Group:Dural Puncture Epidural
DDPE Group:Double Dural Puncture Epidural

Sponsors

First Affiliated Hospital of Gannan Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Primigravida, singleton, cephalic presentation, full-term (=37 weeks), planning for vaginal delivery; 2.Age >= 18 years; 3.Cervical dilation 5; 5.ASA physical status classification II; 6.Voluntarily signs the informed consent form; 7.Feasibility of epidural labor analgesia confirmed after joint assessment by the obstetrician, anesthesiologist, and midwife;

Exclusion criteria

Exclusion criteria: 1.Contraindications to neuraxial anesthesia (e.g., coagulation abnormalities, infection at the puncture site, spinal deformity); 2.Allergy to local anesthetics (ropivacaine or lidocaine) and/or opioids; 3.High-risk pregnancy including placenta previa, preeclampsia, etc. 4.Presence of fetal distress or known fetal abnormalities; 5.History of chronic pain, or concurrent use of analgesics, sedatives, or antidepressants; 6.Language or cognitive barriers that prevent understanding or cooperation with study assessments;

Design outcomes

Primary

MeasureTime frame
Analgesic efficacy at 20 minutes after the initial loading dose;

Secondary

MeasureTime frame
Degree of bilateral lower limb motor block;Time to analgesic onset;Durations of the first and second stages of labor;S2 block attainment and time to S2 block;Maternal satisfaction;Highest sensory block level within 20 min of initial loading dose;Mode of delivery;Time to T10 sensory block;Incidence of adverse events from anesthesia initiation to 24 hours postpartum;Number of parturients requiring rescue analgesia and number of PCEA administrations delivered;VAS pain scores;Neonatal Apgar score;

Countries

China

Contacts

Public ContactHaiyu Xie

First Affiliated Hospital of Gannan Medical University

gyfyxhy@163.com+86 135 7676 7090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026