Comparison of the effect of fentanyl-bupivacaine and sufentanil-bupivacaine on analgesia of spinal anesthesia in pregnant women referring to Ayatollah Mousavi Hospital in Zanjan
Design
The clinical trial has two groups of intervention and control group, based on pragmatic society, with parallel, one blind, randomized groups
Settings and conduct
Firstly, women referred to Ayatollah Mousavi Hospital in Zanjan who were admitted to childbirth and in the active phase of labor in the first stage of labor, with conditions included term pregnancy and no underlying disease. Based on randomized blocking method They are divided into two groups of intervention and one control group. In the first group, 50 μg fentanyl + 2.5 mg bupivacaine and in the second group 5 μg sufentanil + 2.5 mg bupivacaine is injected by number of 25 spinal needle in position of L3-L4 or L4-L5 and after the start of the first stage of delivery (4 cm dilatation in multiparous women and due to slower than delivery 6 cm dilatation in Nulipar women), and no intervention is performed in the third group or control group. Then, the course of delivery and outcomes are studied in all three groups. People are not aware of the drug compound used.
Participants/Inclusion and exclusion criteria
Entry criteria: Women of reproductive age (15 to 35)
Term pregnancy thirty-eight weeks
Starting the first stage of labor
Exit criteria: patient dissatisfaction
Infection in the spinal needle entry site
High blood pressure
Coagulation disorders
History of allergy to narcotic drugs or local anesthetics
Heart disease, kidney, liver disease
Intervention groups
women referring to Ayatollah Mousavi Hospital in Zanjan who are admitted to childbirth and in the active phase of labor in the first stage of delivery with conditions of the study include term pregnancy and lack of underlying illness, based on the randomized blocking method They are divided into two groups of intervention and one control group
Main outcome variables
Duration of first stage of labor; Duration of second stage of labor; time of onset analgesia; Level of sensory and motor block; Duration of analgesia; Type of delivery; Apgar score; Maternal satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160818029414N4
Registration date:2018-03-21, 1397/01/01
Registration timing:registered_while_recruiting
Last update:2018-03-21, 1397/01/01
Update count:0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Vahideh Rashtchi
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 341 1683
Email address
rashtchi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of Fentanyl –Bupivacaine and Sufentanyl –Bupivacaine for Inthrathecal Labour Analgesia in pregnant women.
Public title
Comparision of the addition of Fentanyl and Sufentanil to Bupivacaine on labor analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant woman with age between 15 to 45 and with gestational age between 38 weeks and more
Negative past medical history
One or two gravid
Exclusion criteria:
Patient dissatisfaction
Infection in the site of spinal needle
High intracranial pressure
Coagulation disorders
History of allergy to narcotic drugs or anesthetics
Presence of underlying disease
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The mothers participating in the study after obtaining the informed consent of the spinal anesthesia and explaining the possible side effects of the medication by the anesthetist and the relevant caregiver (clinicians) without mentioning the name
The analgesic group has been shown to be analgesic and the practitioner is also aware of the effects of the medication group. The outcome analyst who is the statistic consultant is also not aware of the medication used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan univercity of medical sciences
Street address
Azadi Avenue
City
Zanjan
Province
Zanjan
Postal code
4515613113
Approval date
2017-08-08, 1396/05/17
Ethics committee reference number
ZUMS.REC.1396.95
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
labor pain
Timepoint
From the time of analgesia to the end of labor or the end of anesthesia
Method of measurement
Based on the questionnaire completed by the researcher, the time is defined in terms of minutes and pain relief based on the pain ruler.
Secondary outcomes
1
Description
Baby apgar
Timepoint
One and a five minutes after childbirth
Method of measurement
The neonatal Apgar score is based on five items: heart rate, muscle tone, baby color, respiratory effort, reflexive irritability. Heart rate less than one hundredth of a person is more than 100 points and in the absence of a score of zero. Irregular respiratory rate score is 1 and A good cry is a score of 2, and in the absence of a score of zero. Your loose muscle is zero and if you have some degrees of flexion, the score 1 and the active motions score 2. If there is no reflexive irritation, the score is zero and in the case of change The baby's face will score one and, in the case of a severe cry, score 2. The pale or blue score is zero, the pink body and The blue endings score one and the whole pink score is 2.
2
Description
Patient satisfaction with analgesia
Timepoint
Immediately after childbirth
Method of measurement
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various
Intervention groups
1
Description
Intervention group: Intervention group: Pregnant mothers were referred to the Mousavi Hospital in the active phase of labor and their first or second term pregnancy. 50 micrograms of fentanyl and 2.5 mg of bupivacaine were injected through the number of 25 spinal needle to space of L3-L4 or L4-L5 in sitting position.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Intervention group: Pregnant mothers were referred to the Mousavi Hospital in the active phase of labor and their first or second term pregnancy. 5 micrograms of Sufentanyl and 2.5 mg of bupivacaine were injected through the number of 25 spinal needle to space of L3-L4 or L4-L5 in sitting position.
Category
Treatment - Drugs
3
Description
Control group: Pregnant mothers who are referred to Mousavi Hospital, who are in the active phase of labor, and their first or second term pregnancy, are examined for the course of labor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Zohre Pishgahi
Street address
Gavazang Avenue
City
Zanjan
Province
Zanjan
Postal code
45139566183
Phone
+98 24 3313 0000
Email
drz.pishgahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza shogli
Street address
Ayatollah Musavi hospital ., Gavazang road
City
Zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 3313 0000
Email
drz.pishgahi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
zohre pishgahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Musavi hospital., Gavazang road
City
zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 3313 0000
Email
drz.pishgahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vahideh Rashtchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Musavi Hospital,Gavazang Avenue
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
vrasshtchi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
zohre pishgahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Musavi hospital.,Gavazang road
City
zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 3313 0000
Email
drz.pishgahi@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