Comparing pain relief methods during normal labor
Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: Single Shot Intrathecal Bupivacaine With Fentanyl Versus Bupivacaine With Dexmedetomidine in Normal Labor, Randomized Control Clinical Trial
PHASE4 · Aswan University Hospital · NCT06823349
This study is testing whether adding fentanyl or dexmedetomidine to a common pain relief medication helps women in labor feel less pain and be more satisfied with their experience.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | Female |
| Sponsor | Aswan University Hospital (other) |
| Locations | 1 site (Aswān) |
| Trial ID | NCT06823349 on ClinicalTrials.gov |
What this trial studies
This randomized control trial aims to evaluate the effectiveness of adding either fentanyl or dexmedetomidine to bupivacaine for single shot spinal analgesia in women undergoing normal labor. Participants will receive one of the study medications, and their pain levels will be assessed using a visual analogue scale before and after the intervention. The study will also monitor maternal satisfaction and the onset and duration of analgesia. Data on demographic and baseline characteristics will be collected to ensure a comprehensive analysis of outcomes.
Who should consider this trial
Good fit: Ideal candidates include pregnant women at term with uncomplicated pregnancies and cervical dilation greater than 5 cm.
Not a fit: Patients with bleeding disorders, infections at the injection site, or those on anticoagulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management options for women in labor, leading to improved maternal satisfaction.
How similar studies have performed: Previous studies have shown promising results with similar analgesic approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-II. * Uncomplicated pregnancy. * At term \& singleton fetus. * Cervical dilatation \> 5cm * Cephalic presentations Exclusion Criteria: * Patient refusal. * Bleeding disorders and patients on anticoagulant drugs. * Infection at site of injection. * Spine deformity. * Allergy to any of study medications.
Where this trial is running
Aswān
- Aswan University Hospital — Aswān, Egypt (RECRUITING)
Study contacts
- Study coordinator: Jehan G Younan, resident doctor.
- Email: jehan.younan1995@gmail.com
- Phone: +20 01222333194
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: Vaginal Delivery, Normal Labor, painless normal labor, Single shot spinal analgesia in vaginal delivery