Color Doppler to Confirm Epidural Catheter Positioning in Parturient

Color Doppler to Confirm Epidural Catheter Positioning in Parturient, Would it Help

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

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: Color Doppler

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: rabab M habeeb; Phone Number: 02 01001970973; Email: rabab_habeeb@med.menofia.edu.eg

Study Locations

• Egypt
  • Menoufia, Egypt, 32817
    • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (C); patients with BMI less than 35	Device: Color Doppler; color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter; Other Names: Epidural catheter
Active Comparator: Group (O); patients with BMI more than 35	Device: Color Doppler; color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter; Other Names: Epidural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity	Number and percentage of patients in both groups where the flow was detected	30 min

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 10/2022ANET1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No