Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour (NCT07327918) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour
Egypt216 participantsStarted 2026-06-28
Plain-language summary
Epidural analgesia is the gold standard for painless labour, but successful catheter placement can be technically challenging due to anatomical and physiological changes in pregnancy. Injecting saline or local anesthetic through the epidural needle before catheter insertion has been proposed to facilitate catheter advancement by dilating the epidural space. This study aimed to evaluate the effect of epidural needle injection on the success rate and ease of catheter placement during labour analgesia.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 18-40 years.
* ASA physical status II or III.
* Singleton pregnancy.
* Gestational age ≥37 weeks.
* Active labour with cervical dilatation ≥3 cm.
* Cephalic presentation.
* Requesting epidural analgesia for painless labour.
* Ability to provide written informed consent.
Exclusion Criteria:
* • Refusal to participate or to sign informed consent.
* Age \<18 or \>40 years.
* ASA status ≥IV.
* Allergy to local anesthetics or saline.
* Coagulopathy or platelet count \<100,000/mm³.
* Local infection at the insertion site.
* Severe spinal deformity (scoliosis, kyphosis).
* Multiple pregnancy.
* Non-cephalic presentation (breech, transverse).
* Antepartum hemorrhage or placenta previa.
* Severe preeclampsia or eclampsia.
* Signs of fetal distress.
* Previous lumbar spine surgery.
* Difficult epidural anatomy (on ultrasound or palpation).
* BMI \>40 kg/m²
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success of epidural catheterization on the first attempt.
Timeframe: Assessed immediately during the procedure at the time of epidural catheter placement.