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

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: Not yet recruiting
• Conditions: Labour Analgesia
• Intervention / Treatment: Procedure: Injection Group; Other: Control group

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Neveen A Kohaf, Ph.D; Phone Number: +201060383012; Email: nevenabdo@azhar.edu.eg

Study Locations

• Egypt
  • Egypt
    • Cairo, Egypt, Egypt, 11865
      • Al-Azhar University
      • Contact: Neveen A. Kohaf, PhD; Phone Number: 01060383012; Email: nevenabdo@azhar.edu.eg
      • Principal Investigator: Hany Baumy, M.D

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of catheterization attempts	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	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	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	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	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

• Sponsor: Al-Azhar University
• Collaborators: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Epidural Needle
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID 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