Comparing hydromorphone and sufentanil for pain relief during labor
Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial
This study is testing whether hydromorphone works better than sufentanil for pain relief during labor when used with a common numbing medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Maternal and Child Health Hospital of Hubei Province Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06036797 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of hydromorphone combined with ropivacaine compared to sufentanil combined with ropivacaine for epidural labor analgesia. Participants will be randomly assigned to four groups, receiving different doses of hydromorphone or sufentanil alongside a consistent dose of ropivacaine. The goal is to determine if hydromorphone offers advantages in pain relief during labor and to identify the optimal dose for effective analgesia.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with a single fetus who are classified as ASA physical status II and can provide informed consent.
Not a fit: Patients with severe respiratory or circulatory diseases, or those with placenta previa, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide improved pain management options for women during labor.
How similar studies have performed: Other studies have explored similar analgesic combinations, but the specific comparison of hydromorphone and sufentanil in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status II * a single fetus * competent to provide informed consent Exclusion Criteria: * severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia * severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy * placenta previa
Where this trial is running
Wuhan, Hubei
- Maternal and Child Health Hospital of Hubei Province — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Na Li, MD — Maternal and Child Health Hospital of Hubei Province
- Study coordinator: Na Li, MD
- Email: lina@hbfy.com
- Phone: +862763490107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.