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Comparison of the prophylactic effects of gabapentin, pregabalin and oral celecoxib and placebo on controlling of postoperative pain in orthopaedic lower extremities surgery with spinal anesthesia

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History
# Registration date Revision Id
2 2018-12-26, 1397/10/05 77067
1 2018-08-07, 1397/05/16 55640
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  • Protocol summary

    One hundred and twenty patients undergoing lower limb orthopedic surgery in Al-Zahra hospital of Isfahan were selected. To make a double- blinded study the patients were unaware of their groups and the physician who has no role in the process of data collection put every drug in the same capsules with different codes.The physician who prescribed the drugs was unaware of drug content of each capsule as well One hour before the act of spinal anesthesia, the drugs were taken and right after the surgery, pain was measured based on the VAS criterion.
    One hundred and twenty patients undergoing lower limb orthopedic surgery in Al-Zahra hospital of Isfahan were selected. To make a double- blinded study the patients were unaware of their groups and the physician who has no role in the process of data collection put every drug in the same capsules with different codes.The physician who prescribed the drugs was unaware of drug content of each capsule as well one hour before the act of spinal anesthesia, the drugs were taken and right after the surgery, pain was measured using the visual analog scale( VAS ).
    120 بیمار تحت عمل جراحي ارتوپدی اندام تحتاني بیمارستان الزهرا شهر اصفهان انتخاب شدند. جهت کورسازی مطالعه بیماران از اختصاص به گروه ها بي اطلاع بوده و پزشکی که در جمع آوری اطلاعات دخالت ندارد داروها را در کپسول های یک شکل با کدهای مختلف گذاشته و پزشک تجویز کننده نیز از محتوای دارویی بی اطلاع است. یک ساعت قبل از انجام بی حسی اسپاینال، داروها تجویز می شوند و پس از انجام عمل جراحی، درد براساس معیار VAS اندازه گیری می شود.
    120 بیمار تحت عمل جراحي ارتوپدی اندام تحتاني بیمارستان الزهرا شهر اصفهان انتخاب شدند. جهت کورسازی مطالعه بیماران از اختصاص به گروه ها بي اطلاع بوده و پزشکی که در جمع آوری اطلاعات دخالت ندارد داروها را در کپسول های یک شکل با کدهای مختلف گذاشته و پزشک تجویز کننده نیز از محتوای دارویی بی اطلاع است. یک ساعت قبل از انجام بی حسی اسپاینال، داروها تجویز می شوند و پس از انجام عمل جراحی، درد براساس معیار(visual analog scale( VAS اندازه گیری می شود.

  • General information

    Not randomized
    Randomized
    1
    1
    Factorial
    Parallel
    2018-07-28, 1397/05/06
    2018-08-11, 1397/05/20
    2018-08-28, 1397/06/06
    2018-10-02, 1397/07/10
    2017-12-22, 1396/10/01
    2018-08-15, 1397/05/24
    2018-04-19, 1397/01/30
    2018-10-09, 1397/07/17
    empty
    2018-10-09, 1397/07/17
    The patients were randomly assigned into four groups of 30, the first, second, third and fourth patients were divided into four groups, and the subsequent patients were randomly distributed in groups so that the sample size Enough in all four groups.
    بیماران انتخاب شده به روش تصادفي سازی بلوکي در چهار گروه 30 نفره توزیع شدند، بدین صورت که بیمار اول، دوم، سوم و چهارم دریكي از چهار گروه قرار گرفته و بیماران بعدی بصورت متوالي درگروهها توزیع شدند تا حجم نمونه به تعداد کافي در هر چهار گروه رسید.

  • Health conditions studied

    #1
    Pain in limb
    Pain in limb, hand, foot, fingers and toes
    Postoperative pain in orthopaedic lower limb surgery
    Postoperative pain of lower limb following orthopaedic lower limb surgery

  • Primary outcomes

    #1
    Post orthopedic surgical pain of the lower extremities
    Post orthopedic sergical pain of the lower extremities

  • Recruitment centers

    #1
    Name of recruitment center - English: Alzahra Hospital
    Name of recruitment center - Persian: بیمارستان الزهرا
    Full name of responsible person - English: dorna kheirabadi
    Full name of responsible person - Persian: درنا خیرآبادی
    Street address - English: N0.10 , Almasian Alley, 7th Alley , East Nazar street
    Street address - Persian: خ نظر شرقی کوچه جوهری کوچه شهید الماسیان پلاک 10
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8173663364
    Phone: +98 31 3624 7909
    Fax:
    Email: dr.dorna.kheirabadii@gmail.com
    Web page address:
    Name of recruitment center - English: Alzahra Hospital
    Name of recruitment center - Persian: بیمارستان الزهرا
    Full name of responsible person - English: Dorna Kheirabadi
    Full name of responsible person - Persian: درنا خیرآبادی
    Street address - English: N0.10 , Almasian Alley, 7th Alley , East Nazar street
    Street address - Persian: خ نظر شرقی کوچه جوهری کوچه شهید الماسیان پلاک 10
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8173663364
    Phone: +98 31 3624 7909
    Fax:
    Email: dr.dorna.kheirabadii@gmail.com
    Web page address:

Protocol summary

Study aim
Comparison of the prophylactic effect of gabapentin, pregabalin and oral celecoxib on controlling of post oprative pain in orthopeadic surgry of the lower extremities.
Design
A clinical trial with a community- based and pragmatic control group with parallel-groups double blind randomised
Settings and conduct
One hundred and twenty patients undergoing lower limb orthopedic surgery in Al-Zahra hospital of Isfahan were selected. To make a double- blinded study the patients were unaware of their groups and the physician who has no role in the process of data collection put every drug in the same capsules with different codes.The physician who prescribed the drugs was unaware of drug content of each capsule as well one hour before the act of spinal anesthesia, the drugs were taken and right after the surgery, pain was measured using the visual analog scale( VAS ).
Participants/Inclusion and exclusion criteria
Inclusion criteria were candidates for elective lower limb orthopedic surgery, absence of uncontrolled systemic diseases. Exclusion criteria include patient's dissatisfaction, failing of spinal anesthesia (it was tried no more than twice maximum)
Intervention groups
An hour prior to spinal anesthesia each group was assigned one of the following three medications. 300mg of Gabapentin was given to the first group, 75mg of Pregabalin to the second group and 200mg of Celecoxib to the third group. Placebo was assigned to the 4th group.
Main outcome variables
Post orthopedic surgical pain of the lower extremities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180722040557N1
Registration date: 2018-08-07, 1397/05/16
Registration timing: prospective

Last update: 2019-01-28, 1397/11/08
Update count: 1
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
Marzie Taghvaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5321 5240
Email address
dr.taghvaie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
2018-08-15, 1397/05/24
Actual recruitment end date
2018-10-09, 1397/07/17
Trial completion date
2018-10-09, 1397/07/17
Scientific title
Comparison of the prophylactic effects of gabapentin, pregabalin and oral celecoxib and placebo on controlling of postoperative pain in orthopaedic lower extremities surgery with spinal anesthesia
Public title
Effect of gabapentin, pregabalin and oral celecoxib on controlling of postoprative pain in orthopaedic lower extremities surgrey
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidacy of elective lower limb orthopaedic surgery No contraindication for spinal anesthesia No restriction for sitting position Patient's tendency to spinal anesthesia No risk of increasing intra cranial pressure No suffering from uncontrolled diseases No coagulation disorders
Exclusion criteria:
Patient's dissatisfaction to keep on coopration Failling of spinal anesthesia (it was tried twice maximally)
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly assigned into four groups of 30, the first, second, third and fourth patients were divided into four groups, and the subsequent patients were randomly distributed in groups so that the sample size Enough in all four groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the current double-blinded study, the patients were unaware of their groups and the physician who did not participate in the process of data collection put all the drugs in the same capsules with different codes.The physician who prescribed the drugs was unaware of drug content of each capsule as well.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Science
Street address
Hezar jarib Ave, Esfahan , Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
396335

Health conditions studied

1

Description of health condition studied
Postoperative pain of lower limb following orthopaedic lower limb surgery
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand, foot, fingers and toes

Primary outcomes

1

Description
Post orthopedic sergical pain of the lower extremities
Timepoint
Each 60 minutes for 2 times and each 6 hours for the next 4 times
Method of measurement
Visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: One hour prior to spinal anesthesia group 1 received 300 mg gabapentin,
Category
Treatment - Drugs

2

Description
Intervention group: One hour prior to spinal anesthesia group 2 received 75 mg pregabalin
Category
Treatment - Drugs

3

Description
Intervention group: One hour prior to spinal anesthesia group 3 received 200 mg celecoxib
Category
Treatment - Drugs

4

Description
Control group: One hour prior to spinal anesthesia control group recieved placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dorna Kheirabadi
Street address
N0.10 , Almasian Alley, 7th Alley , East Nazar street
City
Isfahan
Province
Isfehan
Postal code
8173663364
Phone
+98 31 3624 7909
Email
dr.dorna.kheirabadii@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan university of medical science ,Hezarjerib street,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
Email
haghjoo@bmn.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Esfahan University of Medical Sciences
Full name of responsible person
Marzie Taghvaie
Position
Asistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 17, 6 Ave, Esteghlal Blvd, Shahreza Town
City
Shahreza
Province
Isfehan
Postal code
8618676781
Phone
+98 31 5321 5240
Fax
Email
dr.taghvaie@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamdreza Safavi
Position
Professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra Hospital ,Shohadaye Soffe Blvd, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
safavi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzie Taghvaie
Position
Asistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 17, 6 Ave, Esteghlal Blvd, Shahreza Town
City
Shahreza
Province
Isfehan
Postal code
8618676781
Phone
+98 31 5321 5240
Fax
Email
dr.taghvaie@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
publication of the results
When the data will become available and for how long
Accesibility after data analysis
To whom data/document is available
all researchers in different fields
Under which criteria data/document could be used
They should cite to the paper
From where data/document is obtainable
email to correspond author
What processes are involved for a request to access data/document
He/She should explain about their research clearly and get the permission of all authors.Then He/She can use the data with citation to our paper
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