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A comparative study on the efficacy and safety of programmed epidural intermittent pulse infusion and continuous epidural infusion as background infusion for patient-controlled epidural analgesia in primipara and multiparous women

A comparative study on the efficacy and safety of programmed epidural intermittent pulse infusion and continuous epidural infusion as background infusion for patient-controlled epidural analgesia in primipara and multiparous women

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053511
Enrollment
Unknown
Registered
2021-11-23
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

None listed

Interventions

experimental group:Epidural analgesia with PIEB combined with PCEA
control group:Implementation of epidural analgesia with CEI combined with PCEA

Sponsors

Affiliated Hospital of Ji'ning Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-45 years; 2. Singleton, term (gestational age >= 37 weeks), cephalic pregnancy; 3. Women who deliver vaginally and require labor pain relief; 4. American Society of Anesthesiologists (ASA) grade I-II; 5. No communication barriers, able to cooperate with intervention implementation and operation of patient-controlled analgesia equipment; 6. The subjects participated voluntarily and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with severe heart, lung, liver, kidney and other organ diseases or other system diseases; 2. Those with contraindications for epidural analgesia (infection or trauma at the puncture site, spinal deformity or surgical history, infectious diseases such as bacteremia, or abnormal coagulation, etc.) or allergic to the intended local anesthetic; 3. Those whose body temperature is higher than 37.5 ? before analgesia; 4. Cervical dilation > 3 cm; 5. Known genetic or congenital fetal malformation, fetal growth restriction or oligohydramnios that may be related to placental hypofunction; 6. Patients with malignant tumor or severe preeclampsia; 7. Those with a history of cesarean section, lower abdominal surgery or urological surgery; 8. Long-term use of sedative or analgesic drugs accompanied by systemic diseases; 9. Those with a history of mental illness; 10. Other conditions deemed inappropriate by the competent physician to participate in the clinical study.

Design outcomes

Primary

MeasureTime frame
Analgesic effect;

Secondary

MeasureTime frame
Safety index;

Countries

China

Contacts

Public ContactJia Zhi

Affiliated Hospital of Ji'ning Medical University

jzlmjlcz@sina.com+86 17805370276

Outcome results

None listed

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