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Efficacy and Safety of Hydromorphone or Sufentanil Combined With Programmed Epidural Intermittent Administration of Ropivacaine for Labor Analgesia ---- a Randomized, Controlled, Double-blind, Non-inferiority Study

Efficacy and Safety of Hydromorphone or Sufentanil Combined With Programmed Epidural Intermittent Administration of Ropivacaine for Labor Analgesia ---- a Randomized, Controlled, Double-blind, Non-inferiority Study - Efficacy and Safety of Hydromorphone or Sufentanil Combined With Programmed Epidural Intermittent Administration of Ropivacaine for Labor Analgesia ---- a Randomized, Controlled, Double-blind, Non-inferiority Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100164
Enrollment
Unknown
Registered
2025-04-03
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Labor analgesia

Interventions

Ropivacaine combined with hydromorphone group (Group H):The analgesic drug is 0.1% ropivacaine + 15 ug/ml hydromorphone
Ropivacaine combined with sufentanil group (Group S):The analgesic drug is 0.1% ropivacaine + 0.5 ug/ml sufentanil

Sponsors

Chengdu Pidu District People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) American Society of Anesthesiologists (ASA) classification of I.~II.; (2) Maternal age< 40 years old; (3) Vaginal testing and B-ultrasound extrapelvic measurement before labor, which meet the conditions for natural vaginal delivery; (4) No contraindications to neuraxial anesthesia; (5) singleton full-term cephalic pregnancy; (6) no history of opioid abuse; (7) Pregnant women and their families agreed to participate in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Allergy to the drugs used in this study; (2) Combined with gestational hypertension, placental abruption and other diseases; (3) Combined with diseases of important organs, affecting production or anesthesia; (4) Fetal heart rate monitoring indicates fetal intrauterine distress; (5) Prenatal fever (body temperature greater than 37.3°C) ;(6) Mental illness and inability to cooperate with medical care.

Design outcomes

Primary

MeasureTime frame
VAS score drop value;

Secondary

MeasureTime frame
10min VAS score after the first pulse dose;VAS score 30min after the first pulse dose;VAS score 60min after the first pulse dose;Full-time VAS score of Miyaguchi opening;VAS score at 60 min after delivery;

Countries

China

Contacts

Public ContactLi Junxiang

Chengdu Pidu District People's Hospital

1376015334@qq.com+86 183 4930 1952

Outcome results

None listed

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