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

December 26, 2025 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Egypt
      • Cairo, Egypt, Egypt, 11865
        • Al-Azhar University
        • Contact:
        • Principal Investigator:
          • Hany Baumy, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Injection group
Patients will receive [10 ml of local anaesthetic] through an epidural needle before catheter advancement.
Procedure: Injection Group
Patients will receive [10 ml of local anesthetic] through an epidural needle before catheter advancement.
Placebo Comparator: Control group
No injection before catheter insertion.
Other: Control group
No injection before catheter insertion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Assessed immediately during the procedure at the time of epidural catheter placement.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Assessed during the procedure until successful catheterization is achieved.
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.
Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.
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.
Assessed post-catheter insertion, within the first 30 minutes after drug administration.
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.
Assessed immediately at the time of needle insertion or catheter placement.
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.
Assessed post-delivery, usually within 24 hours after labour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC.11.9.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be shared upon reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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