Comparing two methods of epidural pain relief during labor
Dexmedetomidine for Programed Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia: A Randomized Controlled Double-blind Trial
PHASE2; PHASE3 · Assiut University · NCT05781854
This study is testing two different ways to provide pain relief during labor to see which one helps moms feel more comfortable and manage pain better.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Assiut University (other) |
| Locations | 1 site (Assiut) |
| Trial ID | NCT05781854 on ClinicalTrials.gov |
What this trial studies
This study aims to compare programmed intermittent epidural boluses (PIEB) with continuous epidural infusion (CEI) for labor pain management, using dexmedetomidine alongside low-dose bupivacaine. The research will measure the total volume of local anesthetic administered through patient-controlled epidural analgesia per hour. By evaluating the effectiveness and safety of these two approaches, the study seeks to enhance the quality of labor analgesia for women. The focus is on improving maternal comfort and reducing the stress response associated with labor pain.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 45 years, scheduled for a normal vaginal delivery with a singleton, non-complicated pregnancy.
Not a fit: Patients with a history of cardiac, liver, or kidney diseases, or those with contraindications to regional anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer method of pain relief during labor for women.
How similar studies have performed: Other studies have shown promising results with similar approaches to labor analgesia, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 - 45 years * Scheduled for normal vaginal delivery * ASA physical status ӀI-IӀӀ. * Singleton non-complicated pregnancy. * At least 36 weak of gestation. * Vertex presentation. Exclusion Criteria: * Patient refusal to epidural analgesia. * History of cardiac, liver, or kidney diseases. * History of allergy to amide local anesthetics or study medications. * Any neurological problem. * History of chronic opioid analgesic use. * Any contraindication of regional anesthesia. * Evidence of intrauterine growth restriction or fetal compromise. * Failed or unsatisfactory analgesic block. * Body mass index ≥40 kg/m2
Where this trial is running
Assiut
- Assiut university hospital — Assiut, Egypt (RECRUITING)
Study contacts
- Study coordinator: Hassan Khaled Ahmed Gomaa, Resident
- Email: hassssan.khaled2013@gmail.com
- Phone: 01067319365
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.
Conditions: Labor Pain