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Effect of Ultra-Low Concentration Local Anesthetics with Double-Hole Dural Puncture Epidural Analgesia on Fetal Position and Mode of Delivery: A Randomized Controlled Trial

Effect of Ultra-Low Concentration Local Anesthetics with Double-Hole Dural Puncture Epidural Analgesia on Fetal Position and Mode of Delivery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128772
Enrollment
Unknown
Registered
2026-07-25
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

The contractions and pain during childbirth

Interventions

Study group:U-DDPEA group (0.U-DDPEA group (0.06% ropivacaine double-port spinal puncture epidural analgesia)
Control group:L-EP group (0.1% ropivacaine epidural analgesia)

Sponsors

Dalian Women and Children's Medical Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous women with ASA physical status classification I–II; 2. Gestational age 37–42 weeks, singleton cephalic presentation, in spontaneous labor; 3. Cervical dilation of 2–3 cm, visual analog scale (VAS) score >=40 mm; 4. Willing to participate and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications to neuraxial anesthesia (e.g., coagulation disorders, spinal deformities) or allergy to local anesthetics; 2. Use of opioids or sedatives within 4 hours prior to delivery; 3. Presence of high-risk pregnancy conditions (e.g., preeclampsia, placenta previa); 4. BMI > 40 kg/m^2 or estimated fetal weight >= 4000 g (ultrasound indicating BPD >= 100 mm, HC >= 350 mm); 5. Refusal to participate or presence of communication difficulties, history of mental illness; 6. Accidental dural puncture during epidural insertion or delivery occurring within 1 hour after catheter placement.

Design outcomes

Primary

MeasureTime frame
Fetal position;Mode of delivery;

Secondary

MeasureTime frame
Duration of labor;Maternal and neonatal outcomes;

Countries

China

Contacts

Public ContactJin Meihua

Dalian Women and Children's Medical Group

2856750721@qq.com+86 411 39062317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026