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Completed

NCT Number: NCT05606952

Color Doppler to Confirm Epidural Catheter Positioning in Parturient

The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Menoufia University

Menoufia, 32817, Egypt

About this study

patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • obstetric patients admitted for epidural analgesia in the labor department suite (LDS)

Exclusion criteria

  • Patients suffering from coagulopathy.
  • Patients on recent anticoagulant therapy.
  • Patients suffering from sepsis or with local sepsis at the insertion site.
  • Patients with platelet count less than 100,000/dl.
  • Patient refusal.
  • Patient with known allergy to local anesthetic drugs
  • Patients delivered by forceps.
  • Patients who have undergone a cesarean section delivery.

Treatment and study plan

Color Doppler

Device

color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

Other names: Epidural catheter

Primary outcomes

  1. sensitivity

    Time frame: 30 min

    Number and percentage of patients in both groups where the flow was detected

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Diagnostic Performance of Colour Flow Doppler for Visualization of Epidural Injectate Flow in Labouring Women: A Prospective Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2022
Registry last updated
May 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.

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