Color Doppler to Confirm Epidural Catheter Positioning in Parturient

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05606952
• Other study ID #: 10/2022ANET1-2
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: February 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 10, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Color Doppler
color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

Locations

Country	Name	City	State
Egypt	Menoufia University	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity	Number and percentage of patients in both groups where the flow was detected	30 min