Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07327918

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Labour Analgesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Al-Azhar University

Cairo, Egypt, 11865

Location contact

Hany Baumy, M.D

PRINCIPAL_INVESTIGATOR

Neveen A. Kohaf, PhD

CONTACT

[email protected]

01060383012

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Success of epidural catheterization on the first attempt.

    Time frame: 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

  1. Number of catheterization attempts

    Time frame: 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.

  2. Procedure duration

    Time frame: 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.

  3. Incidence of numbness

    Time frame: 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.

  4. Incidence of unintended dural puncture

    Time frame: Assessed immediately at the time of needle insertion or catheter placement.

    Identifies accidental dural puncture events occurring during epidural space entry or catheter advancement.

  5. Maternal satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neveen A Kohaf, Ph.D

CONTACT

[email protected]

+201060383012

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Benha University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.