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The optimal interval time for programmed intermittent epidural bolus of 0.075% ropivacaine hydrochloride and 4 µg/ml alfentanil hydrochloride for labor epidural analgesia: A biased coin up-and-down sequential allocation trial

The optimal interval time for programmed intermittent epidural bolus of 0.075% ropivacaine hydrochloride and 4 µg/ml alfentanil hydrochloride for labor epidural analgesia: A biased coin up-and-down sequential allocation trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114196
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-20
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Labor pain

Interventions

Epidural analgesia:0.075% ropivacaine combined with 4 µg/ml alfentanil was administered via epidural infusion at different time intervals under the PIEB mode.

Sponsors

The General Hospital of the Northern Theater Command of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Full-term (37-42 weeks), singleton, cephalic presentation, primipara, natural labor or induction of labor, both the mother and the family members agreed to labor analgesia and signed the informed consent form. 2.Age 20-35 years old, height 150-170 cm, body mass index BMI 5 points.

Exclusion criteria

Exclusion criteria: 1.The parturient refused to sign the informed consent form. 2.The parturient was unable to cooperate for the spinal puncture or unable to complete the VAS score. 3.Those who withdrew from the trial halfway or whose results were questionable. 4.Rapid changes in the cervical opening within 1 hour after epidural analgesia (cervical opening dilation >= 5 cm) or delivery within 1 hour after the insertion of the epidural catheter. 5.Allergic to local anesthetics or opioids or having used opioids or sedatives within 4 hours before the epidural catheter insertion. 6.Having contraindications for intraspinal block, such as coagulation dysfunction, puncture site infection or injury, uncorrected maternal hypovolemia or hypotension, increased intracranial pressure, severe spinal deformity, etc. 7.Having gestational diabetes, preeclampsia or eclampsia, placenta previa, fetal intrauterine growth retardation or congenital developmental abnormalities, etc. 8.Having severe dysfunction of heart, liver, kidney or lung, hypotension, low plasma protein.

Design outcomes

Primary

MeasureTime frame
Effective analgesia rate;

Secondary

MeasureTime frame
The VAS score after epidural administration;Maternal perinatal vital signs;Fetal vital signs;Contraction pressure;The occurrence and handling of acute pain;The level of sensory blockage;Bromage score;

Countries

China

Contacts

Public ContactCao Huijuan

The General Hospital of the Northern Theater Command of the People's Liberation Army of China

caohuijuan1212@sina.com+86 133 0988 0882

Outcome results

None listed

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