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Starting soon Not applicable

Effects of Ropivacaine Concentrations on Prolonged Labor Analgesia

NCT07007650 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-06-14
Last updated
2025-06-06

Condition(s) studied

Labor AnalgesiaProlongedRopivacaineConcentration

Investigational drug(s) / intervention(s)

High-concentration RopivacaineLow concentration ropivacaine group

High-concentration Ropivacaine: After the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.

Low concentration ropivacaine group: After the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.

Study summary

With the changes in medical models and improvements in people's quality of life, parturients have higher demands for childbirth, making the alleviation and elimination of labor pain an important aspect of modern obstetrics. Intrathecal labor analgesia has been widely adopted in clinical practice to relieve pain. However, current studies mainly focus on parturients who are just beginning to receive labor analgesia, while for those experiencing prolonged analgesia, medical institutions still use traditional formulations, lacking relevant guidelines or expert consensus. In such cases, prolonged waiting and anxiety may lower the pain tolerance of parturients, leading to an increased need for higher concentrations of local anesthetics. To address this clinical gap, this study aims to explore the effects of different concentrations of ropivacaine in prolonged labor analgesia and has designed a prospective randomized controlled trial (RCT) to provide evidence for improving the analgesic regimen for this group of parturients.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. ASA II 2. Age ≥ 18 years 3. Singleton pregnancy 4. No contraindications for epidural puncture and voluntarily accepting labor analgesia 5. Maternal participants changing the first pump fluid Exclusion Criteria: 1. Contraindications for epidural labor analgesia 2. Serious heart, brain, liver, or kidney diseases 3. Mental abnormalities 4. Neurological diseases 5. Maternal request for management of breakthrough pain before changing the pump fluid

Primary outcome measure(s)

  • Visual Analog Scale (VAS) Pain Score — From pump replacement to the end of labor analgesia.
    The pain will be assessed using the Visual Analog Scale (VAS) at four time points: T0 (at the time of pump fluid change) T1 (0.5 hours after the pump fluid change) T2 (1 hour after the pump fluid change) T3 (when full cervical dilation is achieved/in case of emergency cesarean section).

Trial sites (1)

FacilityCityRegionStatus
Chengdu Jinjiang District Women & Children Health Hospital, Chengdu Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007650 on ClinicalTrials.gov ↗ ← All trials in China