Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour: A Prospective Randomized Study
| Registry | NCT07327918 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 216 (Estimated) |
| Sponsor | Al-Azhar University (Other); collaborators: Benha University |
| Conditions | Labour Analgesia |
| Interventions | Injection Group, Control group (Procedure, other) |
| Dates | start 2026-06-28 (estimated), primary completion 2026-11-30 (estimated), completion 2027-02-15 (estimated), first posted 2026-01-08, last updated 2026-01-08 |
| Locations | 1 site in Egypt |
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All trials for Labour Analgesia All trials of Injection Group All trials of Control group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Injection group | Experimental | Procedure: Injection Group | Patients will receive \[10 ml of local anaesthetic\] through an epidural needle before catheter advancement. |
| Control group | Placebo comparator | Other: Control group | No injection before catheter insertion. |
Sex: Female, ages: 18 Years to 40 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Al-Azhar University | Cairo, Egypt | Egypt |