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Effect of preemptive subcutaneous infiltration of two doses of tramadol on post-operative pain of urologic surgeries, a double-blinded, randomized, placebo-controlled clinical trial.

Protocol summary

Summary
Through this double-blind, randomized, placebo-controlled trial, the effect of subcutaneous preemptive infiltration of two doses of Tramadol on post-operative pain in urologic surgeries will be evaluated. 96 patients who are candidates for urologic surgeries in Ali-Asghar hospital will be randomly assigned into one of the three groups of the trial. Before the incision, patients will receive 1mg/kg Tramadol in 10 cc normal saline 0/9%, 2mg/kg Tramadol in 10 cc normal saline 0/9%, or 10 cc normal saline 0/9% with subcutaneous infiltration at the location of the incision. Pain, sedation score, nausea, vomiting, pulse rate, respiratory rate, and mean arterial pressure will be assessed 15, 30, and 60 minutes and also 4, 8, 16, and 24 hours after surgery

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804222159N1
Registration date: 2010-05-29, 1389/03/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Forugh Ghaedi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 1467 9730
Email address
f_ghaedi@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preemptive subcutaneous infiltration of two doses of tramadol on post-operative pain of urologic surgeries, a double-blinded, randomized, placebo-controlled clinical trial.
Public title
Comparative evaluation the effect of preemptive subcutaneous infiltration of two doses of tramadol on post-operative pain of open kidney and urinary tract surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-75 years old, candidates for urologic surgeries with ASA score I-II Exclusion criteria: history of opiate addiction, history of sensitivity to Tramadol, epilepsy or high ICP, chronic hepatic disease, chronic pain, obesity (BMI>30), taking of MAO inhibitors or SSRIs, any psychological or cognitional disorders that prevent the post operative evaluations, the lack of patient tendency to continue the trial for any reason
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 96
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences-Azadi square –Isfahan
City
Isfahan
Postal code
Approval date
2009-11-22, 1388/09/01
Ethics committee reference number
388328

Health conditions studied

1

Description of health condition studied
post-operative pain after open urologic surgeries
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
degree of pain
Timepoint
15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery
Method of measurement
numeric rating scale

Secondary outcomes

1

Description
nausea and vomiting rate
Timepoint
15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery
Method of measurement
nausea and vomiting score

2

Description
pulse rate
Timepoint
15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery
Method of measurement
count of pulse at a minute

3

Description
sedation rate
Timepoint
15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery
Method of measurement
sedation score

4

Description
respiratory rate
Timepoint
15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery
Method of measurement
count of respiratory rate at a minute

5

Description
mean arterial pressure
Timepoint
15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery
Method of measurement
( 2 × systolic pressure + diastolic pressure ) / 3

Intervention groups

1

Description
Tramadol, 1mg/kg in 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision
Category
Treatment - Drugs

2

Description
Tramadol, 2mg/kg in 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision
Category
Treatment - Drugs

3

Description
Tramadol, 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-Asghar hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences-Azadi square -Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Azim Honarmand
Position
Faculty member
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences-Azadi square -Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
honarmand@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Reza Safavi
Position
Faculty member
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences-Azadi square -Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
safavi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Forugh Ghaedi
Position
student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences-Azadi square -Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
f_ghaedi@edc.mui.ac.ir
Web page address

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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