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Determination of the optimum interval time of programmed intermittent epidural bolus when combined with Dural Puncture Epidural Technique of ropivacaine 0.1% with sufentanyl 0.3 µg/mL for labor analgesia: a biased-coin up-and-down sequential allocation trial

Determination of the optimum interval time of programmed intermittent epidural bolus when combined with Dural Puncture Epidural Technique of ropivacaine 0.1% with sufentanyl 0.3 µg/mL for labor analgesia: a biased-coin up-and-down sequential allocation trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035384
Enrollment
Unknown
Registered
2020-08-09
Start date
2020-08-17
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

labor pain

Interventions

60:interval time of PIEB:60 min
50:interval time of PIEB:50 min
40:interval time of PIEB:40 min
30:interval time of PIEB:30 min

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Healthy nulliparous women aged 20 to 40 years, classified as American Society of Anesthesiologists class II and III who had a singleton vertex presentation at 37–42 weeks gestation in active labor with a cervical dilation between 2 and 5cm as well as a baseline pain score >5 (NRS 0–10, 0 = no pain and 10 = the worst imaginable pain) at the time of request for epidural analgesia will be recruited.

Exclusion criteria

Exclusion criteria: Morbid obesity, pregnancy-related diseases (ie, gestational diabetes, gestational hypertension, cardiopulmonary dysfunction, preeclampsia), history of drug abuse, contraindications to neuraxial blocks, conditions that increase the risk of a cesarean delivery (ie, placenta previa, history of uterine anomaly, or surgery), receipt of parenteral opioids or sedatives in the previous 4 h before epidural analgesia, and known fetal abnormalities. Participants were also excluded from the analysis in the event of an inadvertent dural puncture using the epidural needle, when cerebrospinal fluid (CSF) could not be confirmed with the spinal needle while performing the dural puncture, patients who did not achieve NRS <=3/10 within 20 minutes after the completion of the loading dose, or if a delivery occurred within 1 hour after epidural catheter placement.

Design outcomes

Primary

MeasureTime frame
effective labor analgesia;

Secondary

MeasureTime frame
sensory block level to ice;Numerical Rating Score for pain;Motor strength assessed using Bromage score;maternal noninvasive blood pressure;adverse events;

Countries

China

Contacts

Public ContactYujie Song

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

songyujie@51mch.com+86 13761971889

Outcome results

None listed

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