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The Effect of Epidural Catheter Design on Labor Analgesia under Dural Puncture Epidural Technique combined with Programmed Intermittent Epidural Bolus : a randomized controlled clinical trial

The Effect of Epidural Catheter Design on Labor Analgesia under Dural Puncture Epidural Technique combined with Programmed Intermittent Epidural Bolus : a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088640
Enrollment
Unknown
Registered
2024-08-22
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Labor Pain

Interventions

Experimental group:four lateral ports, close-ended epidural catheter

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women in natural childbirth who require labor analgesia in Shanghai No. 1 Maternal and Infant Health Hospital, primipara with a single fetus; 2. Aged 20 to 40 years; 3. ASA classification I ~ II; 4.The gestational week is 37 to 41 weeks, the regular obstetric examination during pregnancy, regular contractions, requesting epidural analgesia with 2–5 cm cervical dilation; and reporting a baseline pain score =5 on a Numerical Rating Scale (NRS), which evaluates pain from 0 to 10 (0, no pain; 10, worst imaginable pain). 5. To be informed of the methods, risks and purposes of this research, it is necessary to sign an informed consent form and voluntarily participate in this research.

Exclusion criteria

Exclusion criteria: 1. BMI>40kg/m^2; 2. Severe comorbidities or other related complications during pregnancy (ie, cardiac and brain dysfunctions, preeclampsia); 3. History of drug abuse; 4. Contraindications for spinal canal puncture; 5. conditions that increase the risk of a cesarean delivery (ie, placenta previa, history of uterine anomaly, or surgery), and known fetal abnormalities. 6. If a delivery occurred within 1 hour after epidural catheter placement.

Design outcomes

Primary

MeasureTime frame
onset time to adequate labor analgesia ;

Secondary

MeasureTime frame
the percentage of adequate labor analgesia after first bolus;ropivacaine consumption per hour;the time to first patient controlled epidural analgesia;times of rescue epidural analgesics;the number of patient controlled epidural analgesia demand boluses;incidence of hypotension;incidence of motor block;the higest sensor level;maternal satisfactory of labor analgesia;incidence of other side effects;

Countries

China

Contacts

Public ContactZang Yu

Shanghai First Maternity and Infant Hospital

yuzang5499@163.com+86 139 1779 5499

Outcome results

None listed

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