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

NCT ID: NCT07327918

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-28

Study Completion Date

2027-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Labour Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Injection group

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

Group Type EXPERIMENTAL

Injection Group

Intervention Type PROCEDURE

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

Control group

No injection before catheter insertion.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

No injection before catheter insertion.

Interventions

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Injection Group

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

Intervention Type PROCEDURE

Control group

No injection before catheter insertion.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University

Cairo, Egypt, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Neveen A Kohaf, Ph.D

Role: CONTACT

+201060383012

Facility Contacts

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Neveen A. Kohaf, PhD

Role: primary

01060383012

Other Identifiers

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RC.11.9.2025

Identifier Type: -

Identifier Source: org_study_id

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