Protocol summary

Summary
In this clinical trial we are aiming at finding the best way of controlling pain after cesarean section. This is a triple blind study on 120 pregnant women referred to Afzalipour hospital for cesarean section. Exclusion criteria include: patient’s cancellation of entering into this study, bleeding, time consuming surgery, unexpected events, severe pain which needs additional analgesics. Inclusion criteria are: age 20-45 year, weight 60-80kg, primi gravid, no sensitivity or special illness. Visual analogue scale will be taught to all patients who are subjected to the study and then general anesthesia with Thiopental and Succinyl will be given to them. During anesthesia Atracurium and Fentanyl will be administered and finally the anesthesia will be kept on Isoflurane and N2O. The patients will be divided into groups postoperatively. Interventions include administration of suppositories of Indometacine 100mg in group І, Naproxen 500mg in group ІІ, Acetaminophen 325mg in group ІІІ, and Diclofenac 100mg in group ІV, administering rectally when the patient has pain. At the time of arriving a trained nurse who is blind to administered medicine watches and evaluates vital signs and pain, by means of Visual Analogue Scale. After administration of suppository, 15 minutes and one hour after administration, vital signs and pain will be evaluated again. Then information will be recorded in forms and data of any of four groups import in SPSS as codes and analysis will be done. Analyzer will be blind to groups. The blindness will be opened by the manager and data will be interpreted.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205139585N1
Registration date: 2012-12-18, 1391/09/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-12-18, 1391/09/28
Registrant information
Name
Ali Barkhori
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5803
Email address
a_barkhori@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of Diclofenac, Indomethacin. Naproxen and Acetaminophen suppository after cesarean section 
Public title
Comparison of analgesic effect of ُsuppositories after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: primi gravid, term fetus, 37 week or more pregnancy and patients with 20 to 45 years old and weight of 60 to 80 kg indicated for elective surgery. The exclusion criteria: History of allergy to NSAIDs , Bronchial asthma , History of abdominal surgery, Opium addiction , Previous cesarean section, Hemorrhoid , Proctitis , gestational hypertension, preeclampsia, Bleeding tendency, Gastric ingestion ulcers, liver and kidney disease , Patients that refuse to follow the study or severity of their pain needs use of opioid or other analgesics
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Vice chancellor for research, Kerman University of Medical Science
Street address
Shafa Street , Shafa Cross Road
City
Kerman
Postal code
Approval date
2011-02-19, 1389/11/30
Ethics committee reference number
کا/91/60

Health conditions studied

1

Description of health condition studied
Pain after cesarean section
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain

Primary outcomes

1

Description
Pain severity
Timepoint
after drug administration, 15 minutes after drug administration, and an hour later.
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Indomethacin intervention: A trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 100 mg Indomethacin suppository (made by Caspian Tamin with brand name of INDIC) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.
Category
Treatment - Drugs

2

Description
Naproxen Intervention: A trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 500 mg Naproxen suppository (made by Abureyhan Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.
Category
Treatment - Drugs

3

Description
Diclofenac intervention: a trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 100 mg Diclofenac suppository (made by Mahandaroo Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.
Category
Treatment - Drugs

4

Description
Acetaminophen intervention: a trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 325mg Acetaminophen suppository (made by Abureyhan Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital of Kerman
Full name of responsible person
Matin Hashemi
Street address
Emam Khomeini Highway Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hasani
Street address
Ebn Sina Street Tahmasb Abad Cross Road
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Matin Hashemi Shadmehri
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Afzalipor Hospital Emam Khomeini Highway
City
Kerman
Postal code
7618113467
Phone
+98 34 1282 0361
Fax
+98 34 1211 5803
Email
matinhashemi60@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Ali Barkhori
Position
Assistant Professor
Other areas of specialty/work
Street address
Shafa Street. Shafa Hospital
City
Kerman
Postal code
7618751151
Phone
+98 34 1211 5806
Fax
+98 34 1211 5803
Email
a_barkhori@kmu.ac.ir
Web page address
shafah.kmu.ac .ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Dr Mohamad Reza Dourodian
Position
Assistant Professor
Other areas of specialty/work
Street address
Shafa Street. Shafa Hospital
City
Kerman
Postal code
7618113467
Phone
+98 34 1222 1600
Fax
+98 34 1222 1600
Email
Kmu.ac.ir@yahoo.com
Web page address
www.kmu.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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