The ED90 of sufentanil combined with ropivacaine injected into the subarachnoid space for analgesia during labor

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068408

Enrollment

Unknown

Registered

2023-02-17

Start date

2021-11-25

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

labor analgesia

Interventions

The effective group:The next patient has an 8/9 chance of receiving the same dose of sufentanil as the previous woman, and a 1/9 chance of receiving a 0.25ug reduction

The ineffective group:The sufentanil dose was increased by 0.25ug for the next patient

Eligibility

Sex/Gender

Female

Age

19 Years to 33 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy; 2. Primipara; 3. Head delivery; 4. Age of 18 to 35 years; 5. American Society of Anesthesiologists (ASA) class I to II; 6. Full-term (>=37 weeks gestation); 7. Cervical dilatation within 2 to 4 cm; 8. Without cephalopelvic disproportion.

Exclusion criteria

Exclusion criteria: 1. Gesting hypertension; 2. Contraindications to intraspinal anesthesia; 3. Body temperature >= 37.5?; 4. Allergy to local anesthetics and opioids; 5. Previous use of opioid analgesics before epidural analgesia during labor.

Design outcomes

Primary

Measure	Time frame
Sufentanil combined with 0.1% ropivacaine (2.5 mL) was used for subarachnoid block combined with epidural labor analgesia and subarachnoid injection of sufentanil ED90;	—

Secondary

Measure	Time frame
Visual analog score;Maternal adverse reaction: pruritus;Maternal adverse reaction: nausea and vomiting;Maternal adverse reaction: urinary retention;Maternal adverse reaction: respiratory depression;Maternal adverse reaction: hypotension;Maternal adverse reaction: Intrapartum fever;Maternal adverse reaction: Bromage;Abnormal fetal heart rate;Apgar was scored at 1, 5, and 10min;Admission to the neonatal intensive care unit;Duration of labor;delivery mode;Maternal satisfaction;amount of bleeding;Use of oxytocin after analgesia;	—

Measure

Time frame

Visual analog score;Maternal adverse reaction: pruritus;Maternal adverse reaction: nausea and vomiting;Maternal adverse reaction: urinary retention;Maternal adverse reaction: respiratory depression;Maternal adverse reaction: hypotension;Maternal adverse reaction: Intrapartum fever;Maternal adverse reaction: Bromage;Abnormal fetal heart rate;Apgar was scored at 1, 5, and 10min;Admission to the neonatal intensive care unit;Duration of labor;delivery mode;Maternal satisfaction;amount of bleeding;Use of oxytocin after analgesia;

—

Countries

China

Contacts

Public ContactQiaoli Yin; Liqin Deng

Peking University First Hospital Ningxia Women's and Children's Hospital; General Hospital of Ningxia Medical University

2549597170@qq.com+86 13469577852;+86 13909511651

Outcome results

None listed

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