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

NCT07327918 | Not Yet Recruiting Phase 3

• 1 other identifier: RC.11.9.2025
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labour Analgesia

Keywords

Epidural Needle

Outcome Measures

Primary Outcomes (1)

• Success of epidural catheterization on the first attempt.

  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).

  Assessed immediately during the procedure at the time of epidural catheter placement.

Secondary Outcomes (5)

• Number of catheterization attempts

  Assessed during the procedure until successful catheterization is achieved.

• Procedure duration

  Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.

• Incidence of numbness

  Assessed post-catheter insertion, within the first 30 minutes after drug administration.

• Incidence of unintended dural puncture

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

• Maternal satisfaction

  Assessed post-delivery, usually within 24 hours after labour.

Study Arms (2)

Injection group

EXPERIMENTAL

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

Procedure: Injection Group

Control group

PLACEBO COMPARATOR

No injection before catheter insertion.

Other: Control group

Interventions

Injection Group PROCEDURE

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

Injection group

Control group OTHER

No injection before catheter insertion.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Painless Labour
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (1)

Al-Azhar University

Cairo, Egypt, 11865, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Neveen A Kohaf, Ph.D

CONTACT

+201060383012; nevenabdo@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)