Comparing auto-bolus intervals for labor analgesia
The Effect of Changing the Programmed Auto Bolus Interval Time On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study
This study is testing whether giving pain relief during labor every 30 minutes or every 60 minutes works better for women having their first baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT06329713 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how different programmed auto-bolus intervals of local anesthetics affect the quality of labor analgesia using the dural puncture epidural technique. It will be a prospective randomized, controlled, double-blind trial involving healthy nulliparous women aged 20 to 45 during active labor. Participants will be randomly assigned to receive either a 30-minute or a 60-minute interval for auto-bolus administration. The study will assess total anesthetic consumption and the overall effectiveness of pain relief during labor.
Who should consider this trial
Good fit: Ideal candidates are healthy nulliparous women aged 20 to 45 with singleton pregnancies who are in active labor and meet specific medical criteria.
Not a fit: Patients with pregnancy-related comorbidities, contraindications for neuraxial blocks, or those requiring cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of pain management during labor for women, leading to improved childbirth experiences.
How similar studies have performed: While similar studies have explored labor analgesia techniques, this specific approach to auto-bolus intervals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy nulliparous women 2. American Society of Anaesthesiology Score of II 3. During active labor 4. At weeks 37-42. 5. Singlet vertex presentation 6. Cervical dilation \<5 cm at the request of labor analgesia 7. VAS score \>40 Exclusion Criteria: 1. Age \<20 or \>45, 2. Morbid obesity 3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia) 4. History of drug abuse 5. Contrindication for neuraxial blocks 6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries) 7. Diagnosed fetal abnormalities 8. Cases where dura gets punctured unintendedly with the epiduralneedle 9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture 10. Cases where a cesarean section is performed at any stage of labor 11. Cases where labor is completed in 1 hour from the start of analgesia procedure. Exclusion Criteria: -
Where this trial is running
Erzurum
- Atatürk University — Erzurum, Turkey (Recruiting)
Study contacts
- Study coordinator: Ayşenur Dostbil
- Email: adostbil@hotmail.com
- Phone: +905333677796
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.