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Determination of the optimum bolus volume 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 volume of programmed intermittent epidural bolus when combined with Dural Puncture Epidural Technique 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
ChiCTR2300067281
Enrollment
Unknown
Registered
2023-01-03
Start date
2023-01-03
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

None listed

Interventions

Group 1:PIEB bolus: 7 mL
Group 2:PIEB bolus: 8 mL
Group 3:PIEB bolus: 9 mL
Group 4:PIEB bolus: 10 mL
Group 5:PIEB bolus: 11 mL
Group 6:PIEB bolus: 12 mL

Sponsors

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

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. ASA II to III, 37-42 weeks of gestation; 2. 20 years old =5 (NRS 0 to 10, where 0= no pain and 10= the most severe pain imaginable) are eligible for epidural analgesia.

Exclusion criteria

Exclusion criteria: 1. Morbid obesity; 2. Complications of pregnancy such as gestational diabetes mellitus, gestational hypertension, gestational heart disease, preeclampsia, etc.; 3. Drug abuse history, spinal anesthesia contraindications (such as coagulopathy, local anesthesia drug allergy, etc.); 4. The presence of conditions that increase the risk of caesarean section (such as placenta previa, uterine malformations, uterine surgery history); 5. Received opiates or sedatives 4 hours before labor pain relief; 6. Known fetal abnormalities; 7. Patients with epidural needle accident dura puncture, no cerebrospinal fluid reflux after DPE, pain score > 3 within 20 minutes after the first epidural dose, or completion of labor within 1 hour after the start of epidural labor analgesia will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
effective labor analgesia;

Secondary

MeasureTime frame
Numerical Rating Score for pain;sensory block level;Bromage score;adverse events;

Countries

China

Contacts

Public ContactSong Yujie

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 6, 2026