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Comparison the effects of intrathecal Fentanyl and Bupivacaine with Sufentanyl plus Bupivacaine on duration of post-operative pain and side effect in elective caesarean section in alzahra hospital

Protocol summary

Summary
The aim of this study is comparison of effects of intrathecal Fentanyl and Bupivacaine with Sufentanyl plus Bupivacaine on duration of post-operative pain and side effect in elective caesarean section. Inclusion criteria: ASA class 1 & 2: Age between 15-45 years old: Height between 150-170 centimeters Exclusion criteria: Time of operation lasts more than 1.5 hours; Intraoperative bleeding more than 1500 cc; the patient's inability to keep immobility during blocks. 90 patients randomly divided in 3 groups. All patients undergoing intrathecal anesthesia with Bupivacaine. Additionally group F receive Fentanyl, group S receive Sufentanyl and group P injected placebo. During surgery patients will monitor by pulse oximetry, non-invasive barometer and ECG. Blood pressure, heart rate, nausea, vomiting, itching, drowsiness, respiratory depression and Apgar score, sensory block level, motor block level; recovery of sensory block to T10, reversible motor block, pain and shivering and patient satisfaction assessment is evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506068677N6
Registration date: 2015-06-29, 1394/04/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Farnoush Farzi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
farnoush_farzi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of intrathecal Fentanyl and Bupivacaine with Sufentanyl plus Bupivacaine on duration of post-operative pain and side effect in elective caesarean section in alzahra hospital
Public title
The effects of intrathecal Fentanyl and Bupivacaine with Sufentanyl plus Bupivacaine on duration of post-operative pain and side effect in elective caesarean section in alzahra hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 1 & 2: Age between 15-45 years old: Height between 150-170 centimeters Exclusion criteria: The time of operation lasts more than 1.5 hours; Intraoperative bleeding more than 1500 cc; the patient's inability to keep immobility during blocks
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Namjoo Avenue
City
Rasht
Postal code
4193893345
Approval date
2015-05-12, 1394/02/22
Ethics committee reference number
IR.GUMS.REC.1394.23

Health conditions studied

1

Description of health condition studied
Cesarean section
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified

Primary outcomes

1

Description
Painless duration after surgery
Timepoint
The first 15 minutes every 3 minutes, 45 minutes later every 15 minutes, to 4 hours every 30 minutes, 3 hours later every 1 hour and 16 hours later every 4 hours
Method of measurement
According VAS score

2

Description
Using a pressure gauge
Timepoint
Since intrathecal anesthesia to birth every 3 minutes and then every 5 minutes
Method of measurement
Using pressure pomp

3

Description
Neonate APGAR
Timepoint
Minute 1 and 5 According
Method of measurement
APGAR criteria

4

Description
Complications
Timepoint
The first 15 minutes every 3 minutes, 45 minutes later every 15 minutes, to 4 hours every 30 minutes, 3 hours later every 1 hour and 16 hours later every 4 hours
Method of measurement
According patient's history

5

Description
Sensory block level and recovery of sensory block to T10
Timepoint
30 and 60 seconds after injection
Method of measurement
Using Pin prick method

6

Description
Motor block level and recovery of motor block
Timepoint
30 and 60 seconds after injection
Method of measurement
Using Bromage scale

Secondary outcomes

empty

Intervention groups

1

Description
Injection 12.5 milligrams Bupivacaine and 25 microgram Fentanyl
Category
Treatment - Drugs

2

Description
Injection 12.5 milligrams Bupivacaine and 2.5 milligram Sufentanyl
Category
Treatment - Drugs

3

Description
Injection 12.5 milligrams Bupivacaine and 0.5 milliliters normal saline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Farnoosh Farzi
Street address
Namjoo Avenue
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Farnoosh Farzi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Alzahra hospital, Namjoo Avenue
City
Rasht
Postal code
4193713194
Phone
+98 133229524
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com; Farnoush_farzi@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Farnoosh Farzi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Alzahra hospital, Namjoo Avenue
City
Rasht
Postal code
4139638459
Phone
+98 13 3336 8534
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com; farnoush_farzi@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital, Dr. Heshmat st.
City
Rasht
Postal code
4193713194
Phone
+98 13 3336 8534
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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