Evaluation of the effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn
Evaluation of the effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn
Design
A randomized clinical trial, two groups of 30; Epidural : determination of epidural space using loss of resistance to saline, Dural epidural puncture: determination of dural puncture in the axis of epidural needle with needle-through-needle technique and Epidural-spinal : combination of epidural and spinal anesthesia, randomized using the random numbers table.
Settings and conduct
Pregnant women candidates for painless delivery referred to Maryam Hospital with the conditions of entry into the study will be randomly placed in three groups of 30 in one of the Epidural /Dural epidural puncture/Epidural-spinal groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with ASA Class I, II ; Gestation age 38-42 weeks; Candidate for painless delivery.
Exclusion criteria: Contraindications for performing neuraxial analgesia techniques; People who are unable to maintain the position when the needle is inserted; History of spine surgery; Presence of wound and infection at the needle entry site.
Intervention groups
Epidural group: The pregnant woman is placed in a sitting position, then in the L2-L3 or L3-L4 regions with a midline approach, with a 17 gage epidural needle the epidural space is determined using loss of resistance to saline.
Dural epidural puncture group: With the needle-through-needle technique, a Whitacre 25 gage spinal needle is used to confirm dural puncture in the axis of the epidural needle.
Epidural-spinal group: Epidural anesthesia is performed like the epidural group and spinal anesthesia using Quincke 25 gage needle.
In all groups, 8-12 ml of ropivacaine 0.1% is used.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211112053042N4
Registration date:2022-09-29, 1401/07/07
Registration timing:prospective
Last update:2022-09-29, 1401/07/07
Update count:0
Registration date
2022-09-29, 1401/07/07
Registrant information
Name
Mohammad Hossein Delshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 2347
Email address
m.delshad@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-06, 1401/07/14
Expected recruitment end date
2022-12-20, 1401/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn
Public title
The effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with ASA Class I, II
Gestation age 38-42weeks
Singleton
Vertex presentation
Entering the active phase of labor with dilatation less than 5 cm
A candidate for painless delivery
Pregnant women with consent to participate in the project
Exclusion criteria:
Pregnant women with lack of consent to participate in the project
History of back surgery
Diseases related to pregnancy such as gestational hypertension, preeclampsia, gestational diabetes
Contraindications for performing neuraxial analgesia techniques
Known fetal anomaly
A condition with an increased risk of cesarean section, such as a history of previous cesarean section, a history of uterine rupture
Diseases of the central nervous system
Allergy to the drugs used in the study
Coagulation disorders, decreased platelet count
Local or systemic infection
The presence of blood or cerebrospinal fluid in the epidural catheter during the procedure
History of drug abuse
People who are unable to maintain the position when the needle is inserted
History of spine surgery
Presence of wound and infection at the needle entry site
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Study subjects will be divided into three groups, epidural , dural epidural puncture and combined epidural-spinal , using a simple randomization method and using a table of random numbers. First, each person is assigned a number. Then, using the table of random numbers, each selected number is randomly assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher will not have the authority to change the status of the assignment of people or to predict it. Randomization concealment will be done by a third person who does not participate in other stages of the intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-09-23, 1401/07/01
Ethics committee reference number
IR.ABZUMS.REC.1401.168
Health conditions studied
1
Description of health condition studied
Painless delivery
ICD-10 code
O80
ICD-10 code description
Encounter for full-term uncomplicated delivery
Primary outcomes
1
Description
Pain
Timepoint
Before the start of the procedure, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240 minutes after the procedure, cervical dilatation 6 cm, cervical dilatation 10 cm, immediately after the exit of the fetus.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Analgesia onset time
Timepoint
When with the first bolus injection, the pain score is <= 3 based on VAS.
Method of measurement
Ask the patient
2
Description
Movement block
Timepoint
every 15 minutes
Method of measurement
Based on scoring Bromage criteria
3
Description
Sensory block
Timepoint
every 15 minutes
Method of measurement
Sensory block at S2 and T10 levels
4
Description
Systolic blood pressure
Timepoint
Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later
Method of measurement
Measurement with pressure gauge
5
Description
Diastolic blood pressure
Timepoint
Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later
Method of measurement
Measurement with pressure gauge
6
Description
Heart rate
Timepoint
Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later
Method of measurement
Measurement with non-invasive devices
7
Description
Oxygen saturation
Timepoint
Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later
Method of measurement
Pulse Oximetry
8
Description
Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Neonatal specialist examination
Intervention groups
1
Description
The first intervention group: Dural epidural puncture group: With the needle-through-needle technique, a Whitacre 25 gage spinal needle is used to confirm dural puncture in the axis of the epidural needle. 8-12 ml of ropivacaine 0.1% is used.
Category
Prevention
2
Description
The second intervention group: Epidural anesthesia is performed like the epidural group and spinal anesthesia using Quincke 25 gage needle. 8-12 ml of ropivacaine 0.1% is used.
Category
Prevention
3
Description
Control group: Epidural group: The pregnant woman is placed in a sitting position, then in the L2-L3 or L3-L4 regions with a midline approach, with a 17 gage epidural needle the epidural space is determined using loss of resistance to saline. 8-12 ml of ropivacaine 0.1% is used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Maryam Hospital
Full name of responsible person
Mohammad Hossein Delshad MD.
Street address
Arghvan West, 45 meter Golshahr St.
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 9323
Email
m.delshad@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hatam Godini P.H.D
Street address
Saffarian alley, 45 meters from Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
h.godini@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Research centers and faculty members
Under which criteria data/document could be used
At the request of the researcher and faculty members
From where data/document is obtainable
Send email to the scientific respondent
What processes are involved for a request to access data/document
Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people