Color Doppler to Confirm Epidural Catheter Positioning in Parturient
Primary Purpose
Labor Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Color Doppler
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group (C)
Group (O)
Arm Description
patients with BMI less than 35
patients with BMI more than 35
Outcomes
Primary Outcome Measures
sensitivity
Number and percentage of patients in both groups where the flow was detected
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05606952
Brief Title
Color Doppler to Confirm Epidural Catheter Positioning in Parturient
Official Title
Color Doppler to Confirm Epidural Catheter Positioning in Parturient, Would it Help
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Prospective study
Allocation
Non-Randomized
Enrollment
194 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (C)
Arm Type
Active Comparator
Arm Description
patients with BMI less than 35
Arm Title
Group (O)
Arm Type
Active Comparator
Arm Description
patients with BMI more than 35
Intervention Type
Device
Intervention Name(s)
Color Doppler
Other Intervention Name(s)
Epidural catheter
Intervention Description
color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter
Primary Outcome Measure Information:
Title
sensitivity
Description
Number and percentage of patients in both groups where the flow was detected
Time Frame
30 min
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Labour analgesia
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rabab M habeeb
Phone
01001970973
Ext
02
Email
rabab_habeeb@med.menofia.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Color Doppler to Confirm Epidural Catheter Positioning in Parturient
We'll reach out to this number within 24 hrs