Back ground: the cesarean section is one of the most common surgical procedures that is more prevalent in Iran than Western societies. One of the complications of after cesarean section is the pain after surgery that , if not controlled properly, impairs communication between the mothers and their babies causing an unpleasant feeling. The acute pain control after cesarean is of great importance. Regarding the importance of pain control, there is an attempt in this research to compare the effects of two common non-narcotic medications to have a better control over acute pain after cesarean.
Method: This study is a clinical trial. In this study, 88 patients with ASA class I and II at the age of 15-45 who underwent cesarean were selected. 100 mg diclofenac suppository for the first group and 1g of acetaminophen IV in 100 ml normal saline for the second group were repeated immediately after measurement and over 24 hours. The control of postpartum hemorrhage can be assessed by clinical examination, postoperative Hb 6-12 hours after surgery and Pad Score.
Major outcome measures are postoperative pain and bleeding
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081829414N1
Registration date:2016-12-13, 1395/09/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-13, 1395/09/23
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
Zanjan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Diclofenac Suppositories and Intravenous Paracetamol in Postoperative Pain
Public title
the Effect of Diclofenac Suppositories on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: ASA class I,II; age between 15-45 years old; candidate for emergent or elective cesarean section with spinal anesthesia.
Exclusion criteria: when NSAIDS are contraindicated; morbid obesity; HTN; history of cardiovascular, respiratory, coronary artery, renal, gastrointestinal, neuromascular and liver diseases; diabetes; coagulopathy; patients refusal; abnormal bleeding; infection in the site of spinal anesthesia.
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:
88
Randomization (investigator's opinion)
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Approval date
2015-02-06, 1393/11/17
Ethics committee reference number
ZUMS.REC.1393.197
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
XXI
ICD-10 code description
XXI Factors influencing health status and contact with health services
Primary outcomes
1
Description
Postoperative pain
Timepoint
6, 12, 18 and 24 hours after operation
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Postoperative bleeding
Timepoint
6 and 12 hours after operation
Method of measurement
Pad score
Intervention groups
1
Description
In one group 100 mg diclofenac suppository immediately after operation and repeat over 6 hours.
Category
Treatment - Drugs
2
Description
In the other group 1g of acetaminophen IV in 100 ml normal saline administered immediately and every 6 hours for 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Musavi hospital
Full name of responsible person
Dr. Behnaz Molaei
Street address
Ayatollah Musavi hospital, Gavazang road
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shogli
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
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
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
Zanjan University of Medical Sciences
Full name of responsible person
Behnaz Molaei
Position
Gynecologist
Other areas of specialty/work
Street address
Ayatollah Musavi hospital, Gavazang Road
City
Zanjan
Postal code
Phone
+98 24 3313 0000
Fax
Email
Molaei@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vahideh Rashtchi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ayatollah Musavi hospital, Gavazang Road
City
Zanjan
Postal code
Phone
+98 24 3313 0000
Fax
Email
rashtchi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vahideh Rashtchi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Azadi Avenue
City
Zanjan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)