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A randomized sequential allocation study to determine the ED90 values of initial ropivacaine dose under different temperatures using dural puncture epidural technique for epidural labor analgesia

A randomized sequential allocation study to determine the ED90 values of initial ropivacaine dose under different temperatures using dural puncture epidural technique for epidural labor analgesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118550
Enrollment
Unknown
Registered
2026-02-08
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Pain during laboring

Interventions

23? group:All patients received an initial dose of ropivacaine at 23?. The first patient received an initial bolus of ropivacaine (10 mg [0.1%]) combined with sufentanil 0.3 µg/mL in a 10 mL volume
37? group:All patients received an initial dose of ropivacaine at 37?. The first patient received an initial bolus of ropivacaine (10 mg [0.1%]) combined with sufentanil 0.3 µg/mL in a 10 mL volume

Sponsors

Huai'an Hospital Affiliated to Yangzhou University (The Fifth People's Hospital of Huai'an)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged between 18 and 40 years, experiencing a single full - term pregnancy (including primiparas and multiparas), who are scheduled to receive epidural labor analgesia; 2. Cervical dilation less than 5 cm; Visual Analog Scale (VAS) score greater than 5; 3. American Society of Anesthesiologists (ASA) physical status classification grade II.

Exclusion criteria

Exclusion criteria: 1. Contraindicated for epidural labor analgesia, ropivacaine, or sufentanil; 2. Severe pregnancy - related complications (such as heart disease, gestational hypertension, diabetes, etc.); 3. Body mass index (BMI) equal to or greater than 40 kg/m^2; 4. Individuals who utilize other methods for analgesia.

Design outcomes

Primary

MeasureTime frame
The ED90s of the initial ropivacaine bolus required for effective analgesia (VAS score <3 within 30 minutes) under dural puncture epidural ;

Secondary

MeasureTime frame
Visual analogue scale (VAS) score;Bromage score;Apgar score;Adverse event;Delivery related indicators;

Countries

China

Contacts

Public ContactXiangsheng Xiong

Huai'an Hospital Affiliated to Yangzhou University (The Fifth People's Hospital of Huai'an)

158193942@qq.com+86 177 9898 2001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026