Pain management is an important component in the care of the post-cesarean patient. Although there have been innovative advances in pain management and new analgesic modalities, a need still exists for safer and more effective analgesics for the management of pain in the post-cesarean setting.The purpose of this clinical trial is to evaluate the efficacy of preventive administration of iv acetaminophen with respect to postoperative pain control and analgesic requirements in patients undergoing cesarean section with spinal anesthesia. In this double blind and placebo-controlled clinical trial 100 term parturients over 18 years age scheduled for cesarean delivery will be randomize to infuse acetaminophen 1 g into 100 ml normal saline (study group, n=50) or normal saline (placebo group, n=50) 20 minuets before the end of operation. Postoperatively, all patients receive paracetamol iv or diclofenac suppository for 24 hr. Visual analogue scale (VAS; 0 to 10), analgesic requirements, and side effects will be record every hour for four hours then every four hours for a total of 24 hr postoperatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211187013N2
Registration date:2012-12-04, 1391/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-04, 1391/09/14
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Research, Tabriz University of Medicalُ Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEffect of Preventive Analgesia with Paracetamol in Post-Cesarean Section Pain Control
Public title
Preventive Analgesia with Paracetamol for Post-Cesarean Section Pain Control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term parturients; Parturients with over 18 years; Parturients undergoing elective cesarean section with spinal anesthesia.
Exclution criteria:
To have a contraindication for spinal anesthesia; To have allergy to local anesthetics; Patients with mental disorders; Patients with organic dysfunctions; Previous chronic pain; Rased hepatic enzyms.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Vice chancellor for research, Tabriz University of Medicalُ Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
916
Health conditions studied
1
Description of health condition studied
postoperatve pain after cesarean section
ICD-10 code
o75.4
ICD-10 code description
Other complications of obstetric surgery and procedures
Primary outcomes
1
Description
pain
Timepoint
PACU, every 1 hour until 4 hours and then every 4 hours until 24 hours after operation.
Method of measurement
Visual analogue scale (VAS) from 0 (without pain) to 10 (severe and intolerable pain)
Secondary outcomes
1
Description
Analgesic requirements
Timepoint
PACU, every 1 h until 4 h and then every 4 h until 24 h after operation
Method of measurement
Injection number and injection dose in mg
Intervention groups
1
Description
In the study group paracetamol 1 g( volume =6.7ml) into 100 ml normal saline during 15 min, 20 min before the end of operation is infused.
Category
Treatment - Drugs
2
Description
In the placebo group 100 ml normal saline alone during 15 min, 20 min before the end of operation is infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operation Room and Cesarean setting, Al Zahra Hospital,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Operating room, Dr. Simin Atashkhoyi
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Women's Reproductive Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Elahe Olade Saheb Madarek
Street address
Tabriz, Artesh Jonoubi Ave, Al Zahra hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Tabriz, Artesh Jonoubi Ave, Al Zahra hospital
City
Tabriz
Postal code
51386631357
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
satashkhoyi@gmail.com
siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoyi
Position
Associate Professor, Specialist in anesthesiology
Other areas of specialty/work
Street address
Tabriz, Artesh Jonoubi Ave, Al Zahra hospital
City
Tabriz
Postal code
51386631357
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
satashkhoyi@gmail.comsiminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Tabriz, Artesh Jonoubi Ave, AlZahra Hospital
City
Tabriz
Postal code
51386631357
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
satashkhoyi@gmail.comsiminatashkhoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)