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Comparison of equivalent hydromorphone and sufentanil combined with ropivacaine for continuous epidural labor analgesia: a randomized, parallel-controlled, non-inferiority trial

Comparison of equivalent hydromorphone and sufentanil combined with ropivacaine for continuous epidural labor analgesia: a randomized, parallel-controlled, non-inferiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029006
Enrollment
Unknown
Registered
2020-01-11
Start date
2020-01-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Labor Pain

Interventions

Sponsors

Women's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. ASA status I-II; 2. Aged 18-45 years; 3. Body mass index = 37 weeks; 5. Singleton, cephalic, primipara; 6. Epidural analgesia is required, and the cervical dilatation < 3cm; 7. Understand pain scale and Edinburgh depression scale; 8. Those who have not used opioids and other sedative analgesics, and have not used magnesium sulfate; 9. No abnormal fetal heart rate monitoring before labor analgesia (fetal heart rate range 110-160bpm).

Exclusion criteria

Exclusion criteria: 1. Contraindications to neuraxial anesthesia (eg, abnormal coagulation function, infection at puncture site); 2. Those who have difficulty performing epidural procedures (such as scoliosis and ankylosing spondylitis); 3. Allergic to known research drugs 4. Those who use sedative, hypnotic and analgesic drugs within one week 5. History of drug abuse 6. History of sleep apnea syndrome 7. Patients with severe heart, lung, liver, and kidney dysfunction 8. History of bronchial asthma; 9. Combined with pregnancy-related diseases such as hypertension, gestational diabetes.

Design outcomes

Primary

MeasureTime frame
Consumption of ropivacaine per hour;

Secondary

MeasureTime frame
pain score;The frequency and effective frequency of patient-controlled analgesia;additional rescues;Consumption of opioid per hour;Overall pain score during labor;Patient satisfaction;the second stage of labor;the first stage of labor;Oxytocin consumption;mode of delivery;Apgar scores;umbilical artery blood gases;Fetal heart rate;NICU admission;

Countries

China

Contacts

Public ContactYao Zhang

Women's Hospital of Nanjing Medical University

yaozhang@njmu.edu.cn+86 18761853348

Outcome results

None listed

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