The aim of this study is to compare effect of paraacetamol an moderate hydration.In double blind randomized clinical trail, 78 patients candidate for elective open prostatectomy who divide to equals group (n=39). Inclusion criteria are age between 45 till 75 that accept to come to study and Exclusion criteria are history of sensitivity to study medication, patients that received analgesic 8 hours before surgery; patients with psychological problem , any situation that made regional anesthesia contraindicated All the patients in control group receive moderate hydration plus bupiuvacaine .05% up to 3 milliliter. Paraacetamol(intravenous acetaminophen) has some analgesic effects and approved in 2006. In case group all the patients receive paraacetamol after surgery surgery and intratechal bupiuvacaine .05% up to 3 milliliter before surgery. Pain score, need to analgesic drugs, patient satisfaction and time of discharge, will be recorded and analyzed in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306231936N12
Registration date:2015-08-08, 1394/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-08, 1394/05/17
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of medical science
Expected recruitment start date
2015-07-15, 1394/04/24
Expected recruitment end date
2015-09-15, 1394/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Effect of Paracetamol vs Moderate Hydration on Post operative Pain in Open Prostatectomy, A Double Blind Clinical Trail
Public title
The Comparative Effect of Paracetamol vs Moderate Hydration on Post operative Pain in Open Prostatectomy, A Double Blind Clinical Trail
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: elective prostatectomy; age between 45 till 75
Exclusion criteria: history of sensitivity to medication study; patients that received analgesic 8 hours before surgery; patients with psychological problem; addiction and any situation that made regional anesthesia contraindicated
Age
From 45 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
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
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
27/3/92
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
B-15-92-5
Health conditions studied
1
Description of health condition studied
Effect of Apotel and Paraacetamol on Post operative Pain in Open Prostatectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post Operative Pain
Timepoint
24 hours
Method of measurement
Visual
Secondary outcomes
1
Description
Patient Satisfication
Timepoint
24 hours
Method of measurement
Question
Intervention groups
1
Description
In control group all patients receive 20 Milliliters per kilogram normal slain
Category
Treatment - Drugs
2
Description
In intervention group all patient receives 10 milliliters per kilogram intravenous acetaminophen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr University of Medical Science
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Street address
Bushehr University of Medical Science
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr Majid Asadi
Full name of responsible person
Dr.Abdolreza Najafi Anaraki
Street address
Bushehr University of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr Majid Asadi
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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associate Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 1354 0088
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associate professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+087733540088
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr.Abdolreza Najafi Anaraki
Position
Associated Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3354 0088
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)