Improving labor pain relief with a new epidural technique
The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
This study is testing a new epidural technique to see if it can provide better pain relief for women in active labor who need help managing their pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Fujian Provincial Hospital Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT05990504 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Dural Puncture Epidural technique, an enhancement of the Combined Spinal-Epidural method, to improve the quality and safety of labor analgesia. It utilizes ultrasound real-time guidance to ensure accurate positioning and increase the success rate of the procedure. By creating a puncture in the dura mater, the study aims to enhance the delivery of anesthetic drugs from the epidural space to the subarachnoid space, thereby improving pain relief during labor. The study focuses on women in active labor who require epidural analgesia and have a single healthy pregnancy.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women between 37 to 41 weeks of gestation, in active labor with a cervix dilating less than 5 cm.
Not a fit: Patients with pregnancy-related diseases, contraindications to intraspinal analgesia, or those with a history of mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide more effective and safer pain relief for women during labor.
How similar studies have performed: Other studies have shown promise with similar epidural techniques, but this specific approach with ultrasound guidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) Class I or II; 2. Single healthy pregnancy; 3. Head showing first; 4. 37 to 41 weeks; 5. The labor process is active, and the cervix dilates\<5cm; 6. Require epidural labor analgesia; 7. Volunteer to participate in this study and sign an informed consent form. Exclusion Criteria: 1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes; 2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction; 3. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture; 4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate. 5. Patients with long-term use of opioids, steroids, and chronic pain.
Where this trial is running
Fuzhou, Fujian
- Fujian Provincial Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Zongxun Lin, Master — Fujian Provincial Hospital
- Study coordinator: Zongxun Lin, Master
- Email: 13763820916@189.cn
- Phone: +8613763820916
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.