Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour

Al-Azhar University

Status and phase: Begins enrollment in 4 months; Phase 3

Conditions: Labour Analgesia

Treatments: Procedure: Injection Group; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT07327918

RC.11.9.2025

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

Injection group

Experimental group

Description:

Patients will receive \[10 ml of local anaesthetic\] through an epidural needle before catheter advancement.

Treatment:

Procedure: Injection Group

Control group

Placebo Comparator group

Description:

No injection before catheter insertion.

Treatment:

Other: Control group