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The effect of Pretreatment of oral pentoxifylline administration on post-operative pain and development of hyperalgesia in patient under appendectomy surgery

Protocol summary

Study aim
The main objective of this study was to evaluate the effect of oral pentoxifylline premedication on postoperative pain and hyperalgesia in patients undergoing appendectomy.
Design
Clinical trial study of the control and intervention group, randomized double-blind, randomized groups
Settings and conduct
In this study, the independent effect of pentoxifylline administration on postoperative pain, hyperlipidemia, behavioral reactions to pain and appendectomy in patients undergoing appendectomy in a rescue hospital admitted to Sabzevar University of Medical Sciences in 1391-97. In this study, patients and researchers were blinded.
Participants/Inclusion and exclusion criteria
The study population will be 90 patients with men and women admitted to the emergency department. Entry requirements include appendectomy surgery, age range of 15-45 years, non-addiction to cigarettes, alcohol and drugs, lack of mental illness or disease, special areas of interest and participation in the study, and exclusion criteria including liver disease, and a history of seizure.
Intervention groups
Pentoxifylline group: This group receives a dose of pentoxifylline 10 mg / kg for half an hour before surgery. Placebo group: This group receives placebo instead of pentoxifylline half an hour before the placebo.
Main outcome variables
Pain level after surgery, Postoperative analgesic drug intake, The interval between the need for analgesic drug intake, Satisfaction rate, The rate of mechanical hyperalgesia around the wound the expression of TNF- alpha

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180522039773N1
Registration date: 2018-11-24, 1397/09/03
Registration timing: retrospective

Last update: 2018-11-24, 1397/09/03
Update count: 0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Samad Nazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8368
Email address
nazemis@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pretreatment of oral pentoxifylline administration on post-operative pain and development of hyperalgesia in patient under appendectomy surgery
Public title
Pretreatment pentoxifylline and control of post operative pain
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
appendectomy surgery Age range 15-45 years Interested in participating in the study
Exclusion criteria:
Addiction to cigarettes, alcohol and drugs mental illness or a specific disease Sensitivity to Pentoxifylline Liver disease Age over 45 and under 15 years of age
Age
From 15 years old to 45 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, as well as researcher and analyst, do not know the type of intervention performed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Towhid Blvd., Sabzevar University of Medical Sciences, Educational Affairs, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.MEDSAB.REC.1395.47

Health conditions studied

1

Description of health condition studied
Postoperative pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain Scale
Timepoint
6- 12-18-24 Hours after sergury
Method of measurement
VAS test

2

Description
Hyperalgesia
Timepoint
12-24 Hours after sergury
Method of measurement
von Frey test with von frey filaments (180 g)

3

Description
Ramsay Relaxation Scale
Timepoint
12-24 Hours after sergury
Method of measurement
Ramsey Relaxation Questionnaire

4

Description
TNF alpha
Timepoint
24 hours after sergury
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A pentoxifylline dose of 10 mg / kg is given orally in half an hour before anesthesia.
Category
Treatment - Drugs

2

Description
Placebo group: One dose of placebo is given orally to patients half an hour before anesthesia.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Mahtab Khajeh
Street address
Tohid BLvd., Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4465 1300
Email
vasei@medsab.ac.ir
Web page address
http://www.medsab.ac.ir/index.aspx?siteid=1&siteid=1&pageid=158

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Samad Nazemi
Street address
Sabzevar university of Medical Sciences, Faculty of Medicine, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8368
Email
samadnazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Samad Nazemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Medical Sciences, Faculty of Medicine, Department of Physiology, Sabzevar, Iran.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 0514018368
Email
samadnazemi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Samad nazemi
Position
Associtae professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sabzevar University of Medical Sciences, Faculty of Medicine, Department of physiology, sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51440108368
Email
samadnazemi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Samad Nazemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Sabzevar University of Medical Sciences, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8368
Fax
Email
samadnazemi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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