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90% effective (EI90)analgesic interval of ropivacaine combined with hydromorphone using PIEB in epidural labor analgesia for dural perforation

90% effective (EI90)analgesic interval of ropivacaine combined with hydromorphone using PIEB in epidural labor analgesia for dural perforation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094109
Enrollment
Unknown
Registered
2024-12-17
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Labor analgesia

Interventions

A group:0.09% Ropivacaine+5ug/ml Hydromorphone 10ml
B group:0.09% Ropivacaine+10ug/ml Hydromorphone 10ml

Sponsors

Sichuan Jinxin Xinan Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Single-term primipara; 2. American Society of Anesthesiologists (ASA) classification I~II; 3. After the obstetrician's evaluation, the parturient meets the standard of natural delivery conditions; 4. The parturient requires intraspinal analgesia; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. contraindications of intraspinal analgesia, such as puncture site and systemic infection, abnormal coagulation function, intracranial hypertension, etc. 2. allergic to ropivacaine or hydromorphone; 3. Opioid drugs or sedatives (pethidine, nalbuphine, nitrous oxide, etc.) were taken within 4 hours before spinal analgesia was required; 4. Have severe hearing and visual impairment or can't communicate; 5. Patients with failed intrathecal puncture and technical failure of dural puncture (DPE); 6. A numerical rating scale (NRS) score greater than 3 points within 30 minutes after the first dose.

Design outcomes

Primary

MeasureTime frame
90% Effective Analgesia Interval of PIEB;

Secondary

MeasureTime frame
onset;Incidence of side effects;Maternal satisfaction;

Countries

China

Contacts

Public ContactLi Jiaxin

Sichuan Jinxin Xinan Women and Children Hospital

1113734427@qq.com+86 181 0823 7011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026