Determination of adequacy of analgesia and satisfaction of vaginal delivery women with persistent intravenous analgesia with remifentanil infusion and comparing it with epidural analgesia
Determination of adequacy of analgesia and satisfaction of vaginal delivery women with persistent intravenous analgesia with remifentanil infusion and comparing it with epidural analgesia
Design
This study is a randomized clinical trial (with three phases) with parallel groups that will be conducted with the participation of 65 women who are not blind during the study.
Settings and conduct
Women with vaginal delivery referred to Al-Zahra Hospital in Tabriz after random assignment. The women in the intervention group (remifentanil group) will dissolve 4 mg remifentanil in 100cc normal saline solution (40 µg/ml) and the drug will be infused through the infusion pump at a speed of 2 to 4 cc/h. Women in the control group were also implanted under sterile epidural catheter conditions and bolus doses of analgesia containing 15 to 10 ml of marcain 0.650 solution and 15 to 20 μg of fentanyl injected after catheter placement with continuous infusion of the infusion pump containing 100cc of the solution containing mercury 0.650 plus 300 to 400 micrograms of fentanyl is infused at a rate of 4 to 6 ml per hour depending on the severity of the patient's pain.
Women candidates for vaginal delivery will be studied in accordance with inclusion and exclusion criteria after random assignment to control and intervention groups. The women in the intervention group will receive remifentanil intravenously and the women in the control group will receive marcaine through epidural anesthesia. Then the severity of the pain will be compared.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N14
Registration date:2019-12-15, 1398/09/24
Registration timing:prospective
Last update:2019-12-15, 1398/09/24
Update count:0
Registration date
2019-12-15, 1398/09/24
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of adequacy of analgesia and satisfaction of vaginal delivery women with persistent intravenous analgesia with remifentanil infusion and comparing it with epidural analgesia
Public title
Determination of adequacy of analgesia in vaginal delivery with persistent intravenous analgesia with remifentanil compared to epidural analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Perform vaginal delivery
Exclusion criteria:
Women candidates for cesarean section
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
With the help of a randomization list provided by the online statistical software www.randomizer.org, they will be placed into one of two intervention or control groups, respectively.
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 Tabriz University of Medical Sciences
Street address
Azadi Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
1158
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
F45.4
ICD-10 code description
Pain disorders related to psychological factors
Primary outcomes
1
Description
Pain
Timepoint
Every hour for two days
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group women (Remifentanil group) will dissolve 4 mg Remifentanil in 100cc normal saline solution (40µg/ml) and the drug will be infused through infusion pump at a rate of 2 to 4 cc/h . Pain measurement will be done every hour for two days using visual analogue scale.
Category
Treatment - Other
2
Description
Control group: Women in the control group were also implanted under sterile epidural catheter conditions and bolus doses of analgesia containing 15 to 20 ml of marcain 0.650 solution and 15to 20 μg of fentanyl injected after catheter placement with continuous infusion of the infusion pump containing 1cc of the solution containing mercury 0.650 plus 300 to 400 micrograms of fentanyl is infused at a rate of 4 to 6 ml per hour depending on the severity of the patient's pain.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra
Full name of responsible person
Farnaz Moslemi
Street address
Alzahra Hospital, Imam Khomeini Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3449 6369
Email
F.moslemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences , Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Soodabeh Karimi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
s.karimi.h@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
soodabeh Karimi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
59817-64863
Phone
+98 41 3334 7054
Fax
Email
s.karimi.h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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