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Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the EC90 of Ropivacaine with 0.3ug/ml Sufentanil

Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the EC90 of Ropivacaine with 0.3ug/ml Sufentanil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112868
Enrollment
Unknown
Registered
2025-11-20
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

labor analgesia

Interventions

DPE group:Puncture the dura mater, no medication administered, place an epidural catheter, adjust the ropivacaine concentration according to the biased coin sequential method, combined with 0.3 µg/ml
EP group:Traditional epidural block, placing an epidural catheter, adjusting the concentration of ropivacaine according to the biased coin sequential method, combined with 0.3 µg/ml sufentanil

Sponsors

Obstetrics and Gynecology Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women at 37-42 weeks with ASA I-II classification who are willing to undergo labor analgesia; 2. Weight between 50-100 kg and height between 150-180 cm; 3. Cervical dilation =3 when receiving epidural analgesia.

Exclusion criteria

Exclusion criteria: 1. Age 40; 2. Pregnancy-induced hypertension, gestational diabetes, or eclampsia; 3. Mothers with a history of uterine surgery, uterine malformations or abnormalities, placenta previa, or other conditions not suitable for vaginal delivery; 4. Mothers with contraindications to intraspinal anesthesia.

Design outcomes

Primary

MeasureTime frame
Pain;Ropivacaine concentration;

Secondary

MeasureTime frame
Sensory block level;blood pressure;heat beat;adverse effect;drug dosage of patient-controlled analgesia (PCA) pump;

Countries

China

Contacts

Public ContactChen Limng

Obstetrics and Gynecology Hospital, Fudan University

chenliming7706@fckyy.org.cn+86 182 0172 9451

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026