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Effect of epidural infusion rate on analgesic quality of parturient labor when using epidural puncture (DPE) combined with procedural intermittent epidural extrapolation (PIEB)

Effect of epidural infusion rate on analgesic quality of parturient labor when using epidural puncture (DPE) combined with procedural intermittent epidural extrapolation (PIEB)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080904
Enrollment
Unknown
Registered
2024-02-18
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Epidural labor analgesia

Interventions

0.075% Ropivacaine +0.2µg/ml fentanyl PIEB(300mL/h) group:PIEB(epidural infusion rate 300mL/h)
0.075% Ropivacaine +0.2µg/ml fentanyl DPE+PIEB(100mL/h) group:DPE+PIEB(epidural infusion rate 100mL/h)
0.075% Ropivacaine +0.2µg/ml fentanyl DPE+PIEB(300mL/h) group:DPE+PIEB(epidural infusion rate 300mL/h)

Sponsors

Zhejiang Xiaoshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) women between the ages of 18 and 40; (2) ASA Level 2; (3) 37-42 weeks of gestation; (4) Cervical dilation 5(0= no pain, 10= most pain).

Exclusion criteria

Exclusion criteria: (1) intraspinal anesthesia contraindications; (2) Allergic to local anesthetics or fentanyl; (3) morbid obesity; (4) known fetal malformations; (5) Obstetric complications such as gestational hypertension, pre-eclampsia, or gestational or gestational diabetes; (6) refuse to sign the informed consent; (7) Other conditions: history of cesarean section, long-term use of sedatives or analgesics.

Design outcomes

Primary

MeasureTime frame
Proportion of women in each group who had pain outbreaks requiring PCEA or manual intervention by an anesthesiologist.;

Secondary

MeasureTime frame
Consumption of ropivacaine per hour.;Sufficient onset time for analgesia.;Analgesic pump drug use: first PCEA time, number of PCEA compressions, PCEA request/actual compressions ratio.;NRS pain score (NRS pain score before analgesia, 30min, second stage of labor: uterine opening, fetal delivery).;Maternal basic information: age, weight, height, pregnancy, number of pregnancies, uterine opening before labor analgesia, oxytocin use, first stage of labor time, second stage of labor time.;Methods of delivery: natural delivery, forceps delivery, caesarean section transfer cases.;Side effects: nausea, vomiting, itching, chills, hypotension, respiratory depression, excessive sedation, etc.;Neonatal condition: Apgar score 1min 5min.;

Countries

China

Contacts

Public ContactZhong Mei

Zhejiang Xiaoshan Hospital

meizhong@zju.edu.cn+86 189 6997 9723

Outcome results

None listed

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