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A study on the efficacy and safety of modified dural puncture epidural anesthesia combined with programmed intermittent epidural bolus for labor analgesia

A study on the efficacy and safety of modified dural puncture epidural anesthesia combined with programmed intermittent epidural bolus for labor analgesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111550
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-03
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Acute pain in parturients during childbirth

Interventions

Test Group:A 25G puncture needle is used to first perform a subarachnoid puncture at the L2-3 intervertebral space, and then a catheter is inserted at the L3-4 intervertebral space to implement contin
Control Group:Continuous epidural anesthesia via catheter placement in the L3-4 intervertebral space

Sponsors

Maternal and Child Health Hospital of Jiangxi Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Primiparous women with full-term (37 weeks of gestation and above), singleton pregnancy, and cephalic presentation. 2. Classified as Grade II by the American Society of Anesthesiologists (ASA). 3. Cervical dilation less than 5 cm, no obvious obstetric complications, and no contraindications to spontaneous vaginal delivery.

Exclusion criteria

Exclusion criteria: 1. The parturient refuses to participate in this study. 2. Having contraindications to intrathecal anesthesia, including allergies to anesthetics, coagulation dysfunction, spinal deformity, severe hypovolemia, or hemodynamic instability. 3. High-risk pregnancy, such as placenta previa, preeclampsia, etc. 4. Having a history of chronic pain, or long-term use of analgesics, sedatives, or antidepressants. 5. Having communication disorders, a history of mental illness, dysthymia, or a history of epilepsy. 6. The parturient is unable to cooperate with the study or unable to accept interviews.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with adequate analgesia (VAS pain score <= 3) at 10 minutes after intraspinal anesthesia (T1);

Secondary

MeasureTime frame
VAS pain score 20 minutes after intraspinal anesthesia (T2);VAS pain score at 30 minutes after intraspinal anesthesia (T3);VAS pain score when the cervix is fully dilated (T4);Patient Satisfaction Score;Total number of requests for PCEA pump;Total drug consumption of PCEA pump;

Countries

China

Contacts

Public ContactJingzi Rao

Jiangxi Maternal and Child Health Hospital

2856550975@qq.com+86 187 2099 7945

Outcome results

None listed

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