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

NCT07327918 — Phase 3, Not yet recruiting, 216 participants, Al-Azhar University

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Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour: A Prospective Randomized Study

RegistryNCT07327918
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment216 (Estimated)
SponsorAl-Azhar University (Other); collaborators: Benha University
ConditionsLabour Analgesia
InterventionsInjection Group, Control group (Procedure, other)
Datesstart 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
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Labour Analgesia All trials of Injection Group All trials of Control group

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Injection groupExperimentalProcedure: Injection GroupPatients will receive \[10 ml of local anaesthetic\] through an epidural needle before catheter advancement.
Control groupPlacebo comparatorOther: Control groupNo injection before catheter insertion.
  • Injection Group (Procedure): Patients will receive \[10 ml of local anesthetic\] through an epidural needle before catheter advancement.
  • Control group (Other): No injection before catheter insertion.

+Outcome measures

Primary outcomes

  • Success of epidural catheterization on the first attempt. [Assessed immediately during the procedure at the time of epidural catheter placement.]: The incidence of success of epidural catheterization on the first attempt will be determined. This measures whether the epidural catheter is successfully inserted on the first attempt after loss of resistance, without the need for repositioning or reattempt. Success is defined by obtaining adequate analgesia with proper catheter function (confirmed by clinical effect).

Secondary outcomes

  • Number of catheterization attempts [Assessed during the procedure until successful catheterization is achieved.]: Counts the total number of insertion attempts required to achieve correct epidural catheter placement, reflecting technical ease and procedural efficiency.
  • Procedure duration [Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.]: Measures the time elapsed between needle insertion and successful catheter placement, expressed in minutes. Shorter duration indicates greater ease of insertion.
  • Incidence of numbness [Assessed post-catheter insertion, within the first 30 minutes after drug administration.]: Records any occurrence of unexpected or abnormal sensory numbness following the epidural test dose or analgesic administration, which may indicate uneven drug spread or misplaced catheter.
  • Incidence of unintended dural puncture [Assessed immediately at the time of needle insertion or catheter placement.]: Identifies accidental dural puncture events occurring during epidural space entry or catheter advancement.
  • Maternal satisfaction [Assessed post-delivery, usually within 24 hours after labour.]: Evaluates the mother's satisfaction regarding the analgesia quality, comfort during the procedure, and overall experience. Typically rated using a structured satisfaction scale. Maternal satisfaction can be measured on a 0-5 scale using a simple 5-point Likert-type item: 0 = completely dissatisfied, 1 = dissatisfied, 2 = neutral, 3 = satisfied, and 4 = very satisfied.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Al-Azhar UniversityCairo, EgyptEgypt