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Optimal Programmed Intermittent Epidural Bolus Volume for Labor Analgesia with 0.1% Ropivacaine and 0.3 µg/ml Dexmedetomidine with Dural Puncture Epidural Technique: A Biased-Coin Up-and-Down Sequential Allocation Study

Optimal Programmed Intermittent Epidural Bolus Volume for Labor Analgesia with 0.1% Ropivacaine and 0.3 µg/ml Dexmedetomidine with Dural Puncture Epidural Technique: A Biased-Coin Up-and-Down Sequential Allocation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119445
Enrollment
Unknown
Registered
2026-02-27
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Labor Analgesia

Interventions

Sequential experimental group:The biased coin design (BCD) was adopted to explore the effective dose, with dose adjustments performed at 8, 9, 10, 11, 12 and 13 mL. Each parturient started with a dose
for a non-responsive case (PCEA bolus or clinician-administered bolus required), the dose for the next parturient was increased by 1 mL. The initial dose was defined as 10 mL of 0.1% ropivacaine combi
the single administration dose for the first parturient was set at 8 mL.

Sponsors

Women and Children's Hospital, Qingdao University, Qingdao
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy at 37–42 weeks of gestation, nulliparous pregnant women; 2. Aged 20–35 years; 3. American Society of Anesthesiologists (ASA) physical status classification ?–?; 4. Cervical dilation of 2–3 cm with a Visual Analogue Scale (VAS) score of >=6 points; 5. Before the trial, the patients were fully informed of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial, understood the research procedures, and voluntarily signed the informed consent form in writing.

Exclusion criteria

Exclusion criteria: 1.Age 35 years, parous women, advanced maternal age, multiple pregnancy; 2. Morbid obesity, pregnancy-related disorders (i.e., gestational diabetes mellitus, gestational hypertension, and preeclampsia); 3. History of substance abuse, contraindications to neuraxial block; 4. Hypersensitivity to the study drugs; 5. Conditions increasing the risk of cesarean section (i.e., placenta previa, history of uterine anomalies or uterine surgery) and known fetal anomalies.

Design outcomes

Primary

MeasureTime frame
Effective analgesic;

Secondary

MeasureTime frame
Visual analogue scale score;Modified Bromage Scale;Adverse reaction;Sedation Score: Ramsay Sedation Score;

Countries

China

Contacts

Public ContactYongxin Liang

Women and Children's Hospital, Qingdao University, Qingdao

laingzi66@hotmail.com+86 177 0736 5004

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026