Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour
NCT ID: NCT07327918
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
216 participants
INTERVENTIONAL
2026-06-28
2027-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Injection group
Patients will receive \[10 ml of local anaesthetic\] through an epidural needle before catheter advancement.
Injection Group
Patients will receive \[10 ml of local anesthetic\] through an epidural needle before catheter advancement.
Control group
No injection before catheter insertion.
Control group
No injection before catheter insertion.
Interventions
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Injection Group
Patients will receive \[10 ml of local anesthetic\] through an epidural needle before catheter advancement.
Control group
No injection before catheter insertion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Benha University
OTHER
Al-Azhar University
OTHER
Responsible Party
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Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Locations
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Al-Azhar University
Cairo, Egypt, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC.11.9.2025
Identifier Type: -
Identifier Source: org_study_id
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