Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208533831797 Date of Approval: 08/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Color Doppler to confirm epidural catheter positioning in parturient, would it help?
Official scientific title Color Doppler to confirm epidural catheter positioning in parturient, would it help?
Brief summary describing the background and objectives of the trial Labor pain is ranked as one of the most severe type of pain that women experience during their lifetime. Epidural analgesia is the gold standard technique used to decrease labor pain while providing a favorable maternal and fetal safety profile.1 The reported incidence reports of failure of epidural analgesia reached between 13% and 32% depending on the definition of failure adopted done by researchers.2,3 In obstetric population a retrospective study where 75% of patients received epidural analgesia. Results showed an overall failure of 12% while in the same study 6.4% of patients witnessed failure after a preceding time of adequate analgesia.4 To decrease the rate of failure, different confirmatory methods have been proposed as epidural stimulation tests5,6, injection of contrast dye7, detecting epidural space waveform pressures8 and ultrasonography.9 Specific objectives: The primary outcome is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter in BMI < 35 versus BMI > 35 (morbid obese) parturients in labor. Secondary outcome is to detect the percentage of failure of epidural analgesia defined as inadequate analgesia despite adequate dosing at any time during or after initial epidural placement.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2022
Actual trial start date
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 194
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group epidural analgesia for labor pain patients with BMI less than 35 and 10 ml 0.125% bupivacaine 10 ml will be injected by the machine every 30 minutes, Attempt to detect the color flow Doppler and PW will be attempted Initially at parasagittal oblique interlaminar (PO) view by placing the ultrasound probe in the parasagittal plane If colour signals is not visualized on one side of the spine, the PO view will similarly obtained on the other side. If no signals are detected at the level of catheter insertion on either side, the imaging procedure will be repeated at one or, at most, two vertebral levels above and below the site of catheter insertion on either side of the midline If none of the PO views with colour Doppler could detect the catheter, visualization will be attempted using the transverse interlaminar view at the level of catheter insertion and if failed will try in the transverse view one level up. 97 Active-Treatment of Control Group
Experimental Group for patients with BMI more than 35 epidural analgesia for labor pain. 10 ml 0.125% bupivacaine and patient controlled epidural analgesia intermittent dose (10 ml will be injected by the machine every 30 minutes Attempt to detect the color flow Doppler and PW will be attempted Initially at parasagittal oblique interlaminar (PO) view by placing the ultrasound probe in the parasagittal plane If colour signals is not visualized on one side of the spine, the PO view will similarly obtained on the other side. If no signals are detected at the level of catheter insertion on either side, the imaging procedure will be repeated at one or, at most, two vertebral levels above and below the site of catheter insertion on either side of the midline If none of the PO views with colour Doppler could detect the catheter, visualization will be attempted using the transverse interlaminar view at the level of catheter insertion and if failed will try in the transverse view one level up 97
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female in labour age 18_44 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. Adult: 19 Year-44 Year 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/07/2022 Postgraduate Studies Committee
Ethics Committee Address
Street address City Postal code Country
Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine Menoufia 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter in BMI < 35 versus BMI > 35 (morbid obese) parturients in labor. 0 every 30min
Secondary Outcome percentage of failure of epidural analgesia defined as inadequate analgesia despite adequate dosing at any time during or after initial epidural placement. 0every30 min
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine Menoufia 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding Yasin abdelghafar st Shebien Elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia University Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine Menoufia 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabab Habeeb rabab_habeeb@med.menofia.edu.eg 0201001970973 Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine
City Postal code Country Position/Affiliation
Menoufia 32511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Hanaa Elfeky Hanaafotoh@yahoo.mail 0201001970973 Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine
City Postal code Country Position/Affiliation
Menoufia 32511 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Omran Ahmed.omran@med.asu.edu.eg 0201001970973 Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine
City Postal code Country Position/Affiliation
Menoufia 32511 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: “Data obtained through this study may be provided to qualified researchers Study Protocol 12month Epidural,pain, Doppler
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information