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Clinical Application and Effect Observation of Epidural Analgesia Technique with Spinal Dural Penetration in Labor Analgesia

The Clinical Effects of a Modified Dural Puncture-Epidural Analgesia Technique using Ultra-low Local Anaesthetic Concentrations for Labour Analgesia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090854
Enrollment
Unknown
Registered
2024-10-14
Start date
2022-10-25
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Labor Analgesia

Interventions

EP group:Low concentration local anesthetic epidural analgesia:0.1%ropivacaine+0.3ug/ml sufentanil
DPEA1 group:Ultra low concentration local anesthetic for epidural analgesia through a dural puncture site group:0.06%ropivacaine+0.3ug/ml sufentanil
DPEA2 group:Ultra low concentration local anesthetic for epidural analgesia with two dural puncture holes:0.06%ropivacaine+0.3ug/ml sufentanil

Sponsors

Dalian Women and Children’s Medical Group
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: nulliparous women with an ASA physical status of I–II, gestational age = 37–42 weeks, singleton pregnancy, vertex presentation, in active labour with cervical dilatation = 3.0 cm, numeric pain ratings scale (NPRS) > 4, aged 18–40 years.

Exclusion criteria

Exclusion criteria: EP contraindications, gestational hypertension, pregnancy-related diseases (e.g., preeclampsia and gestational diabetes), body mass index (BMI) > 40 kg/m2, biparietal diameter (BPD) = 100 mm, foetal head circumference (HC) = 350 mm, foetal weight = 4000 g and/or women who had taken opioids/sedatives within 4 h prior to EP.

Design outcomes

Primary

MeasureTime frame
Time to NPRS = 2;Additional times of ropivacaine;Total consumption of ropivacaine;Patient satisfaction;Duration of latent period (min);Duration of active period (min);Duration of second stage of labor (min);Oxytocin;

Secondary

MeasureTime frame
Nausea, Vomiting;skin Itch;intrapartum fever;Forceps delivery;Postpartum hemorrhage;Postpartum headache;Fetal location;1-min Apgar score;5-min Apgar score;Bromage score;

Countries

china

Contacts

Public ContactGuangtian Piao; Meihua Jin

Dalian Women and Children’s Medical Group

2856750721@qq.com+86 180 9885 7078

Outcome results

None listed

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