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Color Doppler to Confirm Epidural Catheter Positioning in Parturient

Sponsor
Menoufia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05606952
Collaborator
(none)
194
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Color Doppler
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
194 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Prospective study
Primary Purpose:
Treatment
Official Title:
Color Doppler to Confirm Epidural Catheter Positioning in Parturient, Would it Help
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sensitivity [30 min]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Menoufia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    rabab Mohammad habeeb, Principal investigator, Menoufia University
    ClinicalTrials.gov Identifier:
    NCT05606952
    Other Study ID Numbers:
    • 10/2022ANET1-2
    First Posted:
    Nov 7, 2022
    Last Update Posted:
    Nov 9, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Labor Pain

    Study Results

    No Results Posted as of Nov 9, 2022