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Protocol summary
This study was designed as a double-blind randomized clinical trial with parallel groups and a sample size of 64 patients in each group (128 patients in total).
This study was designed as a double-blind randomized clinical trial with a total sample size of 132 patients (88 people in Epidural and 44 people in Spinal group).
This study was designed as a double-blind randomized clinical trial with parallel groups and a total sample size of 64132 patients in each group (128 patients88 people in totalEpidural and 44 people in Spinal group).
این مطالعه به صورت کارآزمایی بالینی تصادفی دوسویه کور با گروه های موازی و حجم نمونه 64 نفر در هر گروه (جمعا 128 نفر) طراحی شده است.
این مطالعه به صورت کارآزمایی بالینی تصادفی دوسویه کور با حجم نمونه جمعا 132 نفر (88 نفر در گروه اپیدورال و 44 نفر گروه اسپاینال) طراحی شده است.
این مطالعه به صورت کارآزمایی بالینی تصادفی دوسویه کور با گروه های موازی و حجم نمونه 64جمعا 132 نفر (88 نفر در هرگروه اپیدورال و 44 نفر گروه (جمعا 128 نفراسپاینال) طراحی شده است.
گروه A، یا اپیدورال آنالژزی با بوپیواکائین 0.125% به میزان 16 سی سی و فنتانیل 10 میلی گرم
گروه B، آنالژزی اسپاینال با بوپیراکائین 0.5% به میزان 2.5 میلی گرم یا 0.5 سی سی همراه با 10 میلی گرم فنتانیل
گروه A، شامل 88 نفر، اپیدورال آنالژزی با بوپیواکائین 0.125% به میزان 16 سی سی و فنتانیل 10 میلی گرم
گروه B، شامل 44 نفر، آنالژزی اسپاینال با بوپیراکائین 0.5% به میزان 2.5 میلی گرم یا 0.5 سی سی همراه با 10 میلی گرم فنتانیل
گروه A، یاشامل 88 نفر، اپیدورال آنالژزی با بوپیواکائین 0.125% به میزان 16 سی سی و فنتانیل 10 میلی گرم گروه B، شامل 44 نفر، آنالژزی اسپاینال با بوپیراکائین 0.5% به میزان 2.5 میلی گرم یا 0.5 سی سی همراه با 10 میلی گرم فنتانیل
General information
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Changes in sample size due to the lack of eligible and available participants for inclusion in the spinal anesthesia group: According to the consultation with the epidemiologist of the research group, a total of 132 people including 88 people in the epidural group and 44 people in the spinal group were considered in this study.
Changes in sample size due to the lack of eligible and available participants for inclusion in the spinal anesthesia group: According to the consultation with the epidemiologist of the research group, a total of 132 people including 88 people in the epidural group and 44 people in the spinal group were considered in this study.
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تغییر حجم نمونه به علت کمبود نمونه واجد شرایط و در دسترس جهت ورود به مطالعه در گروه بی حسی اسپاینال: طبق مشاوره انجام گرفته با متخصص اپیدمیولوژی گروه تحقیقاتی، تعداد کلی 132 نفر شامل 88 نفر در گروه اپیدورال و 44 نفر در گروه اسپاینال جهت شرکت در این مطالعه در نظر گرفته شدند.
تغییر حجم نمونه به علت کمبود نمونه واجد شرایط و در دسترس جهت ورود به مطالعه در گروه بی حسی اسپاینال: طبق مشاوره انجام گرفته با متخصص اپیدمیولوژی گروه تحقیقاتی، تعداد کلی 132 نفر شامل 88 نفر در گروه اپیدورال و 44 نفر در گروه اسپاینال جهت شرکت در این مطالعه در نظر گرفته شدند.
Participants including pregnant mothers hospitalized in labor. After obtaining informed consent, they are placed in two groups, A and B, for analgesia, but they are unaware of the type of analgesia that is to be performed for them (Epidural or Spinal).
The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia.
The person responsible for collecting the relevant data and completing the form is unaware of the type of analgesia performed.
Participants are unaware of the type of analgesia that is performed for them (Epidural or Spinal). The person responsible for collecting the relevant data and completing the form is unaware of the type of analgesia in patients.
The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia.
Participants including pregnant mothers hospitalized in labor. After obtaining informed consent, they are placed in two groups, A and B, for analgesia, but they are unaware of the type of analgesia that is to be performed for them (Epidural or Spinal). The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia. The person responsible for collecting the relevant data and completing the form is unaware of the type of analgesia performedin patients. The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia.
افراد شرکت کننده که شامل مادران باردار بستری در لیبر می باشند. بعد از اخذ رضایت آگاهانه در دو گروه A و B جهت بی دردری قرار می گیرند اما از نوع روش بی دردی که قرار است برایشان انجام شود ( ابیدورال یا اسباینال) بی اطلاع هستند.
متخصصین بیهوشی که بی دردی توسط ایشان انجام می شود و مراقبان بالینی شرکت کنندگان در طرح از نوع روش بی دردی اطلاع دارند.
فردی که مسؤلیت جمع آوری داده های مربوطه و تکمیل برسش نامه را بر عهده دارد از نوع روش بی دردی انجام شده بی اطلاع است.
بیماران از نوع روش بی دردی که قرار است برایشان انجام شود (اپیدورال یا اسپاینال) بی اطلاع هستند.فردی که مسؤلیت جمع آوری داده های مربوطه و تکمیل برسش نامه را بر عهده دارد از نوع روش بی دردی انجام شده بی اطلاع است.
متخصصین بیهوشی که بی دردی توسط ایشان انجام می شود و مراقبان بالینی شرکت کنندگان در طرح از نوع روش بی دردی اطلاع دارند.
افراد شرکت کننده که شامل مادران باردار بستری در لیبر می باشند. بعد از اخذ رضایت آگاهانه در دو گروه A و B جهت بی دردری قرار می گیرند امابیماران از نوع روش بی دردی که قرار است برایشان انجام شود ( ابیدورالاپیدورال یا اسباینالاسپاینال) بی اطلاع هستند. متخصصین بیهوشی که بی دردی توسط ایشان انجام می شود و مراقبان بالینی شرکت کنندگان در طرح از نوع روش بی دردی اطلاع دارند. فردیهستند.فردی که مسؤلیت جمع آوری داده های مربوطه و تکمیل برسش نامه را بر عهده دارد از نوع روش بی دردی انجام شده بی اطلاع است. متخصصین بیهوشی که بی دردی توسط ایشان انجام می شود و مراقبان بالینی شرکت کنندگان در طرح از نوع روش بی دردی اطلاع دارند.
Protocol summary
Study aim
Comparision of the Effect of Epidural versus Spinal Analgesia on Labor Length and Maternal Satisfaction
Design
This study was designed as a double-blind randomized clinical trial with a total sample size of 132 patients (88 people in Epidural and 44 people in Spinal group).
Settings and conduct
This study will be performed in Arash Women's Comprehensive Hospital.
After the onset of active labor, the severity of cervical dilatation and the suitability of the pelvis for vaginal delivery will be evaluated by a gynecologist. The patient will be evaluated for CVS, RS, and the baseline heart rate, BP, RR, will be recorded in a pre-designed checklist.
An intravenous line will be taken from the non-dominant hand. Ringer's lactate serum in the amount of 500 to 1000 ml is recommended as a preload.
All the tools for managing the airways of the baby will be ready to run the block. Patients were randomly assigned to two groups A, or epidural analgesia with bupivacaine 0.125% at 16 cc and fentanyl 10 mg, and group B ,divide spinal analgesia with 0.5% bupiracaine into 2.5 mg or 0.5 cc with 10 mg fentanyl. Epidural and spinal anesthesia will be performed by an anesthesiologist. The variables will then be collected in a pre-made checklist among patients
Participants/Inclusion and exclusion criteria
All women who are aged 18 to 35 years will be included in the active phase of the first phase of labor and 4-5 cm dilatation and have no contraindication for anesthesia.
Intervention groups
Group A, or epidural analgesia with bupivacaine 0.125% 16 cc and fentanyl 10 mg
Group B, spinal analgesia with bupiracaine 0.5% at 2.5 mg or 0.5 cc with 10 mg fentanyl
Main outcome variables
Labor Duration; Mother's Satisfaction
General information
Reason for update
Changes in sample size due to the lack of eligible and available participants for inclusion in the spinal anesthesia group: According to the consultation with the epidemiologist of the research group, a total of 132 people including 88 people in the epidural group and 44 people in the spinal group were considered in this study.
Acronym
IRCT registration information
IRCT registration number:IRCT20121006011020N14
Registration date:2020-11-03, 1399/08/13
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:1
Registration date
2020-11-03, 1399/08/13
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of Epidural versus Spinal Analgesia on Labor Length and Maternal Satisfaction
Public title
Epidural versus Spinal Analgesia in labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnancy
Cephalic position
Active phase of the first stage of labor
Normal prenatal care
Cervical dilatation above 5-6 cm
Aged between 18 to 35 years old
Height above 150 cm
Body mass index (BMI) between 18-25
The epidemiologist will assign the patient into two groups using the Stata software and the block randomization method. The size of the blocks will be six.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of the type of analgesia that is performed for them (Epidural or Spinal). The person responsible for collecting the relevant data and completing the form is unaware of the type of analgesia in patients.
The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
+981653915981
Approval date
2019-05-13, 1398/02/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.077
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Labor Duration
Timepoint
During Labor (From 0 to 4 stage of labor)
Method of measurement
Chronometer Watch
2
Description
Mother's Satisfaction
Timepoint
At the end of the study
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Epidural analgesia with bupivacaine 0.125% 16 cc and fentanyl 10 mg
Category
Treatment - Drugs
2
Description
Intervention group 2: Spinal analgesia with 0.5% bupiracaine 2.5 mg or 0.5 cc with 10 mg fentanyl
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr. Maryam Khoshideh
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
khooshide@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Shaababni
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
z.shabani1988@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Khooshide
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Khoshideh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
+98 21 7788 3196
Email
khooshide@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available