Pain after abdominal hysterectomy is a multi-factorial moderate to severe pain, so use of different analgesic techniques for appropriate postoperative pain relief have been discussed for many times. One of these approaches is prevention of severe postoperative pain with early administration of analgesics, before surgical intervention and tissues trauma, which called preemptive analgesia. There are controversies about the effect of acetaminophen in preemptive analgesia. The aim of this study is to evaluate the effect of preemptive acetaminophen on postoperative pain relief after abdominal hysterectomy. Following approval from the Local Ethics Committee and receipt of written informed consent, 90 patients who are candidate for abdominal hysterectomy will be enrolled into the study in two groups.group 1 will be received 1 gm acetaminophen in 100 ml normal saline in 30minutes.group 2 will be received only 100 ml normal saline. Pain will be assessed and recorded by Visual Analogue Scale after arrival to the recovery and at 1st, 2, 4, 6,8,12 and24 th hours postoperatively. Pethidine 0.5-1 mg/kg IV will be administered to the patients with VAS ≥4. First analgesic request, total additional petidine doses, and any probable postoperative complications including will be recorded. All date will be statistically analyzed using SPSS v.16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012611700N4
Registration date:2014-02-05, 1392/11/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-05, 1392/11/16
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effect of preoperative Paracetamol after abdominal hysterectomy
Public title
The Effect of preoperative Intravenous Paracetamol on Postoperative Pain Management after Total Abdominal Hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with 25-80 years old; patients with ASA physical status I,II,III; patients candidate abdominal hysterectomy; patients who have informed consent
Exclusion criteria: patients with ASA physical status higher than III; patients with cardiovascular and respiratory disease; patients who had pain and received analgesic
Age
From 25 years old to 80 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
Vice Chancellor for Research,Tabriz university of Medical sciences
Street address
Tabriz university of Medical sciences,Golgasht Ave,Tabriz
City
Tabriz
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
92107
Health conditions studied
1
Description of health condition studied
acute postoperative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
immediatly and 2th ,4,6, 8,12,24 postoperatively
Method of measurement
visual analogue scale (0= non to 10= severe pain) cm)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1(Intervention) will be received infusion of 1 gm acetaminophen in 100 ml normal saline in 30 minutes.
Category
Treatment - Drugs
2
Description
Group 2(control) will be received only infusion of100 ml normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farnaz Moslemi
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Street address
Alzahra Hospital, South Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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. Farnaz Moslemi
Position
Associate Professor of Anesthesiology, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospitai, South Azarbayejan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 984115566449
Email
Moslemi_fa@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
Dr. Farnaz Moslemi
Position
Associate Professor of Anesthesiology, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 984115566449
Email
Moslemi_fa@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. Farnaz Moslemi
Position
Assiciate Professor of Anesthesiology, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, Soouth Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 984115566449
Email
Moslemi_fa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)