Color Doppler to Confirm Epidural Catheter Positioning in Parturient

NCT ID: NCT05606952

Last Updated: 2024-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-11-10

Brief Summary

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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

Detailed Description

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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.

Conditions

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Labor Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Prospective study

Study Groups

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Group (C)

patients with BMI less than 35

Group Type ACTIVE_COMPARATOR

Color Doppler

Intervention Type DEVICE

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

Group (O)

patients with BMI more than 35

Group Type ACTIVE_COMPARATOR

Color Doppler

Intervention Type DEVICE

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

Interventions

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Color Doppler

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

Intervention Type DEVICE

Other Intervention Names

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Epidural catheter

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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rabab Mohammad habeeb

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia University

Menoufia, Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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10/2022ANET1-2

Identifier Type: -

Identifier Source: org_study_id

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