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Observation on the Clinical Effects of Different Concentration Gradients of Ropivacaine Hydrochloride in Individualized Full-Course Epidural Labor Analgesia

Observation on the clinical effects of different concentration gradients of ropivacaine in full-course epidural labor analgesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090294
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-10-08
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Labor Analgesia

Interventions

control group:Loading Dose: 12 - 15 ml of the mixture of 0.1% Ropivacaine Hydrochloride and 0.3 µg/ml Sufentanil Citrate. Administration Method: 10 ml every 30 minutes for programmed intermittent epid
the study group:Loading Dose: 12 - 15 ml of the mixture of 0.06% Ropivacaine Hydrochloride and 0.3 µg/ml Sufentanil Citrate. Administration Method: According to the progress of labor and the analgesic

Sponsors

Dalian Women and Children’s Medical Group
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) ASA graded I-II primitives, 37 to 42 weeks gestation, single head position, natural labor; 2) Uterine dilation of 2 cm, digital pain assessment scale (NPRS) score > 4, age 18-40 years; 3) Prenatal examination No contraindications for vaginal delivery, no contraindications for intraspinal anesthesia, and no obstetric-related complications.

Exclusion criteria

Exclusion criteria: EP contraindications, gestational hypertension, pregnancy-related diseases (e.g., preeclampsia and gestational diabetes), body mass index (BMI) > 40 kg/m^2, biparietal diameter (BPD) = 100 mm, foetal head circumference (HC) = 350 mm, foetal weight = 4000 g and/or women who had taken opioids/sedatives within 4 h prior to EP.

Design outcomes

Primary

MeasureTime frame
Time to NPRS = 2;Total consumption of ropivacaine;Additional times of ropivacaine;Patient satisfaction;Duration from the Implementation of Labor Analgesia to the Latent Period (min);Duration of active period (min);Duration of second stage of labor (min);Total Amount of Oxytocin;

Secondary

MeasureTime frame
Nausea, Vomiting;skin Itch;intrapartum fever;Forceps delivery;Postpartum hemorrhage;Incidence Rate of Urinary Retention 8 Hours after Delivery;Incidence Rate of Headache 48 Hours after Delivery;1-min Apgar score;5-min Apgar score;Bromage score;Observe the Feeling of Anal Distension in Parturients;

Countries

China

Contacts

Public ContactMeihua Jin

Dalian Women and Children’s Medical Group

2856750721@qq.com+86 180 9885 7078

Outcome results

None listed

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