Comparing higher volume and lower dose local anesthetics for labor pain relief
The Effect of Using Local Anesthetics in a Higher Volume and Lower Dose On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study
This study is testing if using more local anesthetic at a lower strength can help women in labor feel less pain compared to using a smaller amount at a stronger strength.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT06156709 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of using a higher volume of local anesthetics at a lower concentration during labor analgesia with the dural puncture epidural technique. It will be a prospective randomized, controlled, double-blind trial involving healthy nulliparous women aged 20 to 45 who are in active labor. Participants will be randomly assigned to two groups: one receiving a lower volume with higher anesthetic concentration and the other receiving a higher volume with lower concentration. The study will assess total anesthetic consumption and the quality of pain relief experienced by the participants.
Who should consider this trial
Good fit: Ideal candidates are healthy nulliparous women aged 20 to 45 in active labor with singleton pregnancies.
Not a fit: Patients with pregnancy-related comorbidities or contraindications for neuraxial blocks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of labor analgesia while potentially reducing the total amount of anesthetic required.
How similar studies have performed: While similar approaches have been explored, this specific comparison of higher volume and lower dose in labor analgesia 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.
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.