Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Injection Group, Control group.
- Who it may be relevant to
- Registry conditions: Labour Analgesia. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour: A Prospective Randomized Study
Overview
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.
Interventions
- Procedure Injection Group
Patients will receive \[10 ml of local anesthetic\] through an epidural needle before catheter advancement. - Other Control group
No injection before catheter insertion.
Primary outcome measures
- Success of epidural catheterization on the first attempt. [Time frame: Assessed immediately during the procedure at the time of epidural catheter placement.]
Secondary outcome measures (5)
- Number of catheterization attempts [Time frame: Assessed during the procedure until successful catheterization is achieved.]
- Procedure duration [Time frame: Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.]
- Incidence of numbness [Time frame: Assessed post-catheter insertion, within the first 30 minutes after drug administration.]
- Incidence of unintended dural puncture [Time frame: Assessed immediately at the time of needle insertion or catheter placement.]
- Maternal satisfaction [Time frame: Assessed post-delivery, usually within 24 hours after labour.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Al-Azhar University — Cairo
Identifiers
NCT: NCT07327918 · RC.11.9.2025