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Comparison of the efficacy of bupivacaine in combination with sufentanil or bupivacaine in combination with meperidine or bupivacaine alone in spinal anesthesia in patients undergoing elective cesarean section

Protocol summary

Study aim
Aim was comparison efficacy of bupivacaine in combination with sufentanil or bupivacaine in combination with meperidine or bupivacaine alone in spinal anesthesia in patients undergoing elective cesarean section.
Design
The phase 3 clinical trial with a control and parallel group, not blinded and unrandomized on 135 patients in three groups.
Settings and conduct
This evaluation is a clinical trial in phase 3, of pregnant women with indications for elective cesarean section and approved by a gynecologist at Ali ibn Abi Talib Hospital, as the study group. 135 cases with inclusion criteria are selected. Patients fall into three groups with non-randomized allocation without blinding, 45 cases in the first and 45 cases in the second intervention group and 45 in the control group.
Participants/Inclusion and exclusion criteria
Pregnant women with 17 to 45 years of age and class of American Society of Anesthesiologists 1 or 2 will include as study group, also patients with dissatisfaction with study, coagulopathy, increased intracranial pressure, injection site infection, severe intravascular volume decline, severe sensitivity to anesthesia and opioids, pregnancy hypertension, cesarean section requiring blood transfusion, chronic itching, emergency cesarean section because of fetal distress and longer than 1.5 hours of operation excluded from study.
Intervention groups
Before surgery, the first group received 12.5 mg of bupivacaine from Aburaihan pharmaceutical company along with 20 mg of meperidine from caspian pharmaceutical company, and =second group received 12.5 mg of bupivacaine from Aburaihan pharmaceutical company with 2.5 micrograms of sufentanil manufactured by Darou Pakhsh pharmaceutical company was used and in third group only 12.5 mg of bupivacaine was used by Abourihan pharmaceutical company.
Main outcome variables
Severity of pain after cesarean section

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191010045048N1
Registration date: 2019-10-18, 1398/07/26
Registration timing: prospective

Last update: 2019-10-18, 1398/07/26
Update count: 0
Registration date
2019-10-18, 1398/07/26
Registrant information
Name
Neda Norozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3457 3756
Email address
dr.nnorouzi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of bupivacaine in combination with sufentanil or bupivacaine in combination with meperidine or bupivacaine alone in spinal anesthesia in patients undergoing elective cesarean section
Public title
Comparison the effectiveness of bupivacaine in spinal anesthesia with meperidine and sufentanil in patients undergoing elective cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 17 to 45 years of age Class of American Society of Anesthesiologists 1 as or 2
Exclusion criteria:
Patient dissatisfaction Coagulopathy Increased intracranial pressure Injection site infection Drastic decrease in intravascular volume Severe sensitivity to anesthetics and opioids Pregnancy hypertension Cesarean section requires blood transfusion Chronic itching Emergency cesarean section due to fetal distress Operation length greater than 1.5 hours
Age
From 17 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Zahedan University of Medical Sciences
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-10-04, 1398/07/12
Ethics committee reference number
IR.ZAUMS.REC.1398.248

Health conditions studied

1

Description of health condition studied
Spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anesthesia during pregnancy

Primary outcomes

1

Description
Time to reach the T10 anesthesia
Timepoint
During surgery
Method of measurement
Physical examination

2

Description
The time to reach the highest level of Dermatome anesthesia
Timepoint
During surgery
Method of measurement
Physical examination

3

Description
Anesthesia down to T10 level
Timepoint
During surgery
Method of measurement
Physical examination

4

Description
Time to reach full block
Timepoint
After surgery
Method of measurement
Physical examination

5

Description
Motor recovery time
Timepoint
After surgery
Method of measurement
Physical examination

6

Description
Postoperative drowsiness
Timepoint
After surgery
Method of measurement
Physical examination

7

Description
Amount of Diclofenac consumption
Timepoint
After surgery
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, 12.5 mg of bupivacaine, manufactured by Aboureihan pharmaceuticals, along with 20 mg of meperidine, manufactured by Caspian pharmaceuticals, were used before surgery.
Category
Treatment - Drugs

2

Description
Intervention group: In this group, 12.5 mg of bupivacaine, manufactured by Aboureihan Pharmaceuticals, along with 2.5 micrograms of sufentanil manufactured by Darou Pakhsh pharmaceutical company, were used before surgery.
Category
Treatment - Drugs

3

Description
Control group: In this group, only 12.5 mg of bupivacaine produced by Aboureihan pharmaceutical company was used before surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ibn Abi Talib Hospital
Full name of responsible person
Neda Noruzi
Street address
9816743463, Ali Ibn Abi Talib Hospital, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Email
dr.nnorouzi@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Shahraki
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5725
Email
m_Shahrakim@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Neda Noruzi
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Email
dr.nnorouzi@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Asadullah Shakeri
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Email
Ashakeri123@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Neda Noruzi
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Email
dr.nnorouzi@zaums.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
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